Manager – Corporate Quality Assurance (P2P)

Responsibilities:-

1. Evaluation of new proposal and projects towards commercial suitability

2. To review and approve the QMS documents generated at contract manufacturing sites.

3. To schedule audit plan of contract mfg. sites on yearly basis based on business / project proposals and priorities.

4. To inspect contract manufacturing sites as per schedule and monitor GMP compliance

meeting regulatory requirements of respective market.

5. To Review and Assess the data received from all such sites to ensure compliance to GDP/ GLP.

6. To monitor validation and qualification activities performed at sites and ensure their compliance to the cGMP guidelines.

7. To ensure compliance of CAPA on the observations noted during various regulatory inspections performed at P2P sites.

8. To Review Investigation reports of market complaints and ensure appropriate CAPA based on root cause identified.

9. To ensure compliance and closure to various queries received from regulatory authorities or customers through co-ordination with Regulatory Assurance department.

10. To enhance co-ordination with supply chain to ensure getting documents from P2P pertaining to complaints, CAPAs or any changes which directly or indirectly impacts business timelines.

11. To travel and visit to warehouses and / or CnFs for investigation and auditing the facility.

12. To review stability data being generated at P2P sites and monitor trend of OOS/OOT , if any.

13. To provide Trainings to the personals from each contract manufacturing site in terms of documentation or regulatory requirements as and when required.