Job Description

About the company:

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

Key KRAs

1. Planning and scheduling Of QA activities relating to drug product packaging operations and medical devices operations.

2. Planning and scheduling of QA activities related to Ware house operations including product dispatch activities.

3. Handling of document management & Audit management teams.

4. Ensure validations activities like, Shipping validations, Devices assembly process validation [Pen assembly process validation & packaging process validations]

5. Investigate, review and approval medical device related complaints.

6. Review of Packaging profiles and Device related documentation.

7. Ensure compliance in the areas of Ware house, Packaging area and Medical devices facilities.

8. Ensure Executed BMR, BPR and DR reviewed.

9. Batch disposition (Approval/ rejection as applicable) to release to the market or intended purpose.

10. Preparation and Reviewing of QA related documents and approval.

11. Approval for Reprocessing and repacking (wherever applicable).

12. Handling of rejected / recalled materials.

13. Reviewing documents [Procedures (SOP, IOP, EOP, GAM, and Specifications etc.), validation protocol and reports, checklists, qualification documents etc.] Of other departments.

14. Shall participate in Self-inspection/ internal audits and external audits.

15. Ensure periodic mock recalls conducted as per approved SOP.

Experience 15 Plus years