Granules India Ltd is a fast growing pharmaceutical supplier based in one of the most dynamic economies of the world, serving all major markets worldwide.

At Granules, we don’t just deliver products to our customers, but also provide business solutions, built on partnerships for mutual growth. From a small beginning dating back to 1984 and having reached to this level now at a fast pace, we are destined to grow larger and bigger.

We believe that this exciting journey has been made possible by over +2,150 strong workforce. Our strength rests on our diverse workforce and the rich experience they bring, across varied skillsets and backgrounds. We are bound together by common values to which each of us remain highly committed in our journey to realise our vision. We also believe that it is our workforce which will enable us scale greater heights and take us on a growth trajectory.

Current Openings

Applicants can forward resumes via email to Elizabeth.diaz@granulespharma.com

 

Position Description

Name Open
Position Title: Quality Compliance Associate
Job Code: Grade: (Compensation/HR Use Only)
Location: Chantilly, VA Department: QA
Last Updated (Date): Workers Comp Code: (Compensation/HR Use Only)

Job Summary

The QA Associate ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines. The persons is responsible for the execution and oversight of the cleaning and process validation activities as well.

Principle Accountabilities

JOB DESCRIPTION& RESPONSIBILITIES
  • Ensure that products meet approved company policies, process and procedures.
  • Perform In-process Quality assurance job functions and support to the manufacturing operations
  • Perform and support maintenance and closure activities of documents such as reports, change controls, protocol review.
  • Drive the timely implementation and closure of change controls while ensuring compliance to applicable quality standards and change control procedures.
  • Author and review standard operating procedures.
  • Prepare and execute cleaning validation/verification documentsalong with calculation of the acceptance criteria for all equipment available at the site.
  • Perform the release of finished product batches packaged in house and from contract packagers.
  • Help in the completion and organization of vendor qualification documentation
  • Preforms all labeling activities from the creations to the management of changes.
  • Ensure labeling requirements are met as per company SOP’s, which includes incoming inspection and release.
  • Knowledge in the serialization of pharmaceutical products.
  • Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls and complaints.
  • Any other activity as assigned by the Supervisor

Management Responsibility Reports to

Quality Compliance Associate Director

Internal/External Contacts

N/A

Knowledge & Skills

  • Demonstrate knowledge in process and cleaning validation/qualification.
  • Knowledge of Quality Management Systems, including FDA compliance standards, cGMP regulations/guidelines.
  • Knowledge of USFDA regulations/guidance’s and ICH guidance’s.
  • Knowledge of Change Control/Deviation management and CAPA identification/implementation.
  • Proficient in Microsoft Word, Excel, Power Point.
  • Knowledge of labeling requirements for the pharmaceutical industry.
  • Ability to analyze data/information and to assess and resolve complex issues, as required.
  • Ability to work and communicate with cross-functional teams.
  • Ability to manage multiple priorities and re-prioritize tasks, as required.
  • Flexible and able to adapt to company growth and evolving responsibilities.
  • Strong attention to detail and excellent organization.
  • Excellent oral and written communication skills.

Experience & Education

  • Bachelor’s degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
  • At least one (1) to three (3) years’ experience in a quality assurance role in a cGMP-regulated environment.

Physical Requirements/Working Environment

  • While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.
  • Light to moderate lifting up to 10-15 lbs. is required.

Travel

Up to 5 % travel may be necessary.

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Position Description

Name Open
Position Title: QA Technician
Job Code: Grade:
Location: Chantilly, VA Department: QA
Last Updated (Date): Workers Comp Code:

Job Summary

The QA technician ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.

Principle Accountabilities

JOB DUTIES & RESPONSIBILITIES
  • Manage and maintain company document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements.
  • Manage the routing, review, approval, distribution and archival of new and revised controlled documents.
  • Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports.
  • Archive and maintain hardcopy and electronic copies of batch records files, audit files, vendor files, product, label files and change history files.
  • Provide guidance and training to employees on document control systems and document management procedures.
  • Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures.
  • Collaborate with team members and site customers to ensure timely deliverables for documentation.
  • Any other activity as assigned by the Supervisor

OTHER or ADDITIONAL RESPONSIBILITIES

If any job assigned by supervisor.

Management Responsibility

  • cGMP compliance in Document control
  • Ensuring all documents are up to date with respect to version control and issuance

Reports to

QA- Manager- Vidur Shah

Internal/External Contacts

N/A

Knowledge & Skills

  • cGMP compliance within the pharmaceutical manufacturing industry.
  • Writing and maintaining cGMP documentation.
  • Analyze data/information and resolve complex issues.
  • Verbal and written communication skills.
  • Work and communicate with cross-functional teams.
  • Multiple priorities and re-prioritize tasks.

Experience & Education

  • At least three to three (3) years’ experience in a quality assurance role in a cGMP-regulated environment.
  • A college Degree preferably in Sciences (i.e. Biology, Chemistry etc.)

Physical Requirements/Working Environment

  • While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.
  • Specific vision abilities required by this job include close vision requirements due to computer work.
  • Ability to sit at a computer terminal for an extended period.
  • Light to moderate lifting up to 10-15 lbs.is required.
  • Ability to work in a confined area.

Travel

5 %

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Job Responsibility

JOB SUMMARY

- a concise overview of the job and the expected results

Cleaning Operator is to perform a variety of cleaning and maintenance duties in manufacturing area. The Duties will include Cleaning of processing equipment, vacuuming, mopping, surface cleaning, dusting of GMP area.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeCleaning/Manufacturing Process

  • Cleans and maintains processing rooms and equipment as per SOP.
  • Maintaining and upkeep of all cleaning equipment, supplies, and products
  • Disposing of trash from bins and containers.
  • Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal, local laws and safety rules and regulations.
  • Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
  • GMP compliance in a regulated work environment.
  • Manufacturing processes and equipment procedures.
  • Basic math skills.
  • Record keeping skills.
  • Different units of measurement, i.e., milligrams, grams, kilograms, liters and gallons.

Documentation

  • Completes documentation associated with cleaning processes (e.g. Cleaning Checklist, protocols, and logbooks) with detail and accuracy.
  • Meets requirements for entries on all applicable documents
  • Verifies the cleaning process is accurate and timely manner.
  • Provides status updates and operational challenges on status boards.

Continuous Improvement

  • Assists in troubleshooting process issues; refers deviations from standard procedure to the supervisor.
  • Typically participates in at least one continuous improvement project of a moderate scope and complexity.

Safety & Compliance

  • Adheres to all cGMP compliance/regulatory mandates and quality requirements.
  • Participates in safety teams, start-up discussions, incident debriefing sessions, etc.
  • Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
  • Maintain a clean, organized, work area. Training
  • Conforms to all training requirements, including company required and machine-specific training.

Teamwork & Collaboration

  • Contributes to team and project success by sharing previously acquired knowledge.
  • Collaborates typically within own cross-functional work unit and occasionally with contacts outside own unit or department.

Education & Experience

  • Minimal acceptable level of education, work experience and certifications required for the job
  • HS diploma or equivalent with a minimum of 1 year of manufacturing experience and certification in assigned area, as required or proficiency demonstrated in competencies as required.
  • Forklift certification may be required for certain jobs.

Knowledge

  • Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc
  • Has solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.
  • Basic math, reading, legible writing skills, and problem-solving abilities.

Skills & Abilities

  • Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writingetc
  • Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
  • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
  • Attendance/Punctuality - Is consistently at work and on time; Arrives at meetings and appointments on time.
  • Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
  • Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
  • Comply with all Company policies and procedures.
  • Comply with all Company safety rules and regulations.

Physical Requirements

  • Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
  • Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
  • Vision - ability to see details at close range (within a few feet of the observer).
  • Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness.
  • Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.

Disclaimer:

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Job Responsibility

JOB SUMMARY

- a concise overview of the job and the expected results

The Operator, The Manufacturing Operator performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeManufacturing Process

  • Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, Encapsulating, Coating, potent compound, etc. Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs.
  • Executes written SOPs to ensure the purity of materials involved in the manufacturing process.
  • Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.
  • Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.
  • Cleans manufacturing equipment and facilities according to established SOPs.
  • Executes machine changeovers from batch to batch.
  • May sample batches for quality testing. Executes required in-process product quality checks and documents accurately.
  • Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward.

Documentation

  • Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
  • Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.
  • Verifies the manufacturing process on BPR in an accurate and timely manner.
  • Provides status updates and operational challenges on status boards.

Continuous Improvement

  • Assists in troubleshooting process issues; refers deviations from standard procedure to the supervisor.
  • Typically participates in at least one continuous improvement project of a moderate scope and complexity.

Safety & Compliance

  • Adheres to all cGMP compliance/regulatory mandates and quality requirements.
  • Participates in safety teams, start-up discussions, incident debriefing sessions, etc.
  • Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
  • Maintain a clean, organized, work area.

Training

  • Conforms to all training requirements, including company required and machine-specific training.

Teamwork & Collaboration

  • Contributes to team and project success by sharing previously acquired knowledge.
  • Collaborates typically within own cross-functional work unit and occasionally with contacts outside own unit or department.

Education & Experience

  • Minimal acceptable level of education, work experience and certifications required for the job
  • HS diploma or equivalent with a minimum of 2-4 years of manufacturing experience and certification in assigned area, as required or proficiency demonstrated in competencies as required.
  • Forklift certification may be required for certain jobs.

Knowledge

  • Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc.
  • Has solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.
  • Basic math, reading, legible writing skills, and problem-solving abilities.

Skills & Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writingetc.

  • Proficient in running machinery.
  • Proficient in (Master Clean/Surface clean) equipment cleaning.
  • Proficient in sampling batches.
  • Proficient in doing basic set-ups.
  • Ability to participate in Continuous Improvement projects.
  • Qualified in any of the following manufacturing processes:
  • Weighing
  • Blending
  • Granulation
  • Compression
  • Coating
  • Encapsulation
  • Potent Compound
  • Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
  • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
  • Attendance/Punctuality - Is consistently at work and on time; Arrives at meetings and appointments on time.
  • Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
  • Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
  • Comply with all Company policies and procedures.
  • Comply with all Company safety rules and regulations. Physical Requirements
  • Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
  • Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
  • Vision - ability to see details at close range (within a few feet of the observer).
  • Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness.
  • Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.

Disclaimer:

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Position Description

Position Title: Associate Chemist
Job Code: Grade: (Compensation/HR Use Only)
Location: GPI Chantilly Department: Analytical Laboratory
Last Updated (Date): Workers Comp Code: (Compensation/HR Use Only)

Job Summary

The role of QC Associate chemists responsible for performing routine and non-routine analytical testing raw materials, in-process, finished formulations, stability samples and cleaning validations under the supervision from the Quality control team lead. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Responsible for the safe and efficient execution of job duties

Principle Accountabilities

JOB DUTIES & RESPONSIBILITIES:
  • Conduct routine analytical testing of raw materials, packaging materials, finished product release and stability using approved methods and various instrumentation (HPLC, Dissolution apparatus,UV-Vis, FT-IR and KF Auto titrator) while adhering to cGMP and established policies.
  • Perform routine cleaning method validation/verification under the supervision.
  • Perform routine analytical balances daily verification and standardization of Karl fisher for water content determination.
  • Prepares necessary reagents (Mobile phase, Dissolution mediums) and Set-up the analytical equipments (HPLC, Dissolution baths) for routine testing.
  • Compile laboratory test data and perform appropriate analyses that include physical (solubility, viscosity), chemical (titration) and analytical (FTIR, HPLC, UV-Vis, KF) testing etc.
  • Complete documentation needed to support testing procedures including test forms and logbooks.
  • Interpret test results, compare them to established specifications and control limits, and ensure appropriateness of data for release. Treats data with a high level of integrity and ethics.
  • Participate in out-of-specification and failure investigations. Support all aspects of laboratory investigations
  • Provide general laboratory support; such as routine instrument cleaning/preventive maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.

Management Responsibility

NA

Reports to

Team lead or designee of Analytical Laboratory.

Internal/External Contacts

Yes

Knowledge & Skills

Preferred:

Strong knowledge of the major analytical techniques: HPLC/UPLC, GC, dissolution, FT-IR, etc. Strong knowledge of FDA/ICH regulations.

Experience & Education

BS Chemistry or science related field. Minimum of one (1) year experience in using analytical instrument techniques (HPLC,FT-IR, UV-Vis, Dissolution Apparatus, Ovens/Auto Titrators/KF Titrator, etc.).

Physical Requirements/Working Environment

  • Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
  • Commitment to long hours of work when necessary to achieve goals.
  • Respirator, lab coat and safety glasses required. Ability to work with potent substances using a glove-box.

Travel

No Travel requirement.

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Position Description

Position Title: Biochemist
Job Code: Grade: (Compensation/HR Use Only)
Location: GPI Chantilly Department: Analytical Laboratory
Last Updated (Date): Workers Comp Code: (Compensation/HR Use Only)

Job Summary

The role of QC Biochemist/chemist II is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical testing raw materials, in-process, finished formulations, stability samples, method development and/or transfers, and cleaning validations. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Responsible for the safe and efficient execution of job duties

Principle Accountabilities

JOB DUTIES & RESPONSIBILITIES:
  • Conduct routine analytical testing of raw materials, packaging materials, finished product release and stability using approved methods and various instrumentation (HPLC, Dissolution apparatus,UV-Vis, FT-IR and KF Auto titrator) while adhering to cGMP and established policies.
  • Perform routine cleaning method validation/verification under the supervision.
  • Perform routine analytical balances daily verification and standardization of Karl fisher for water content determination.
  • Prepares necessary reagents (Mobile phase, Dissolution mediums) and Set-up the analytical equipments (HPLC, Dissolution baths) for routine testing.
  • Compile laboratory test data and perform appropriate analyses that include physical (solubility, viscosity), chemical (titration) and analytical (FTIR, HPLC, UV-Vis, KF) testing etc.
  • Complete documentation needed to support testing procedures including test forms and logbooks.
  • Interpret test results, compare them to established specifications and control limits, and ensure appropriateness of data for release. Treats data with a high level of integrity and ethics.
  • Participate in out-of-specification and failure investigations. Support all aspects of laboratory investigations
  • Provide general laboratory support; such as routine instrument cleaning/preventive maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.

Management Responsibility

NA

Reports to

Team lead or designee of Analytical Laboratory.

Internal/External Contacts

Yes

Knowledge & Skills

Preferred:

Strong knowledge of the major analytical techniques: HPLC/UPLC, GC, dissolution, FT-IR, etc. Strong knowledge of FDA/ICH regulations.

Experience & Education

BS Chemistry or science related field. Minimum of one (1) year experience in using analytical instrument techniques (HPLC,FT-IR, UV-Vis, Dissolution Apparatus, Ovens/Auto Titrators/KF Titrator, etc.).

Physical Requirements/Working Environment

  • Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
  • Commitment to long hours of work when necessary to achieve goals.
  • Respirator, lab coat and safety glasses required. Ability to work with potent substances using a glove-box.

Travel

No Travel requirement.

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.