JOB DESCRIPTION
Job Title
Strategic Sourcing Head - SCM
Grade
C / D
Reporting To
SCM Head
Location
Gagillapur Unit- Hyderabad, India
Purpose
Develop and drive Procurement strategy for raw materials, packaging material and capital equipment’s by identifying and qualifying cost effective vendors to ensure timely supply of products.
Responsibilities
- Lead procurement of Raw Material & Packaging Material for FD/API /PFI along with procurement related to engineering revenue expenditure and CAPEX Projects for Hyderabad Units (GGP, JDM & BPL-1). Also, responsible for Sourcing of materials for new product development as per timelines.
- Prepare procurement budget for ABP and monitor purchases as per. Based on demand / forecast, plan material procurement to ensure desire OTIF.
- Finalise vendor contracts including prices, specifications, delivery terms, credit period etc for RM/PM and other CAPEX / engineering related materials. Plan and ensure annual contracts with Suppliers in terms of quantity, price, slab wise rebates. Monitor the same and ensuring receipt of the rebates. Ensure compliance to legal agreements and any other mutually developed documents like joint services documents, quality agreements etc. Arrange & coordinate Vendor Audits as per SOP.
- Monitor daily procurement activities of materials, safety stock / lead time including placing indents, giving delivery schedules to ensure that there is no stock-out/overstock at any point of time. Monitor GIL prices with respect to the market prices and use EXIM data. Resolve emergent situation arising out of unplanned shutdown / stock outs of certain critical materials due to high consumption or any other reasons.
- Vendor development & evaluation- Identify & develop business relations with potential vendors / suppliers for achieving cost effective purchase of material in coordination with CFT. Assess vendor’s performance based on various criteria such as quality systems, timely delivery, credit terms, etc.
- Interact with vendors on various complaints (OOS & OOT in-house) including customer complaints and ensure timely implementation of CAPAs.
- Create & review MIS report periodically. Undertake improvement projects to optimize material cost, payable days and Inventory.
- Guide & mentor direct-reports, conduct periodic review of their work-performance and facilitate development. Ensure Purchase personnel are appropriately trained and qualified to perform their job responsibilities. Create awareness of new Purchase regulations that impacts the business and communicate changes to the concern.
Qualifications and Experience
- Bachelor Degree in Pharmacy or Chemical Engineering /Science graduate or Masters in Organic Chemistry /Any post graduate with @20 years of experience in Pharmaceutical / Chemical industry Purchase /SCM function. Experience in leading Procurement /Material management function for API / Finished dosages plants adhering to regulatory norms.
Knowledge and Skills
- Sound working knowledge of ERP like SAP etc.
- Excellent Negotiation & Influencing Skills.
- Good networking and liaison skills.
- Able to seamlessly collaborate with various cross functional departments to drive business results.
- Communication Skills.
JOB DESCRIPTION
Department
Regulatory affairs
Job Title
Analyst
Grade
B
Reporting To
SM
Location
Granules – Gagillapur Plant –Hyderabad
Purpose
Provide support as a team member of Regulatory affairs in supporting various works on DMF filings and Queries handling.
Responsibilities
- Provide support for Compilation of dossiers (Drug master files) and submitting to various regulatory agencies.
- Preparation of dossiers as per USFDA, EDQM, ASMFs, Heath Canada, WHO and other regulatory agencies dossier requirements.
- Preparation of responses to queries received from customers and regulatory agencies.
- Experience in change controls evaluation.
- Preparation of DMF Amendments/CEP revisions/Other DMF updates to support life cycle management of product.
- Hands on exposure in pharma ready eCTD software handling for US, Europe and Canada markets requirements.
- Ensuring the PDF properties of Dossiers for uploading into pharma ready eCTD software based on regulatory market requirements for converting PDF document in to XML backbone. Further the complete dossier is zip filed and submitted in to ESG gateway of USFDA and CESP portal of EU agencies.
- Liaising with internal customers and stakeholders to ensure coordination of all projects.
- Provide support for continuous improvement in existing procedures/practices/compliance of department.
- Provide support in the overall management of the Regulatory affairs department and create a healthy environment of teamwork and empowerment, and promoting the values of creativity, integrity, excellence, perseverance, flexibility and respect.
Qualifications and Experience
- Master’s degree or equivalent in Pharmaceutical or Chemistry or Pharmacy or Life Sciences
- 3-8 years’ experience in Regulatory affairs – API DMF filings.
Knowledge and Skills
- Candidates must have experience of working in a generic pharmaceutical company.
- Demonstrated interpersonal skills.
- Knowledge and application of ICH Guidelines, DMF, EDMF / GMPs, GLPs, and GCPs principles.