Sr Manager - Quality Control - Pharma

Requirements:

- Around 10-15 years of experience in Quality Control function from a reputed.

- Pharmaceutical company of which at least 5 years should have been in a leadership Position.

- Should have lead the QC team in Client & Regulatory audits.

- Should have faced successful USFDA & MHRA audits in the last two years.

- Should be currently working at a regulated plant.

Area of Responsibility:

- Procedures & Systems (Review and updation of SOPS , set up of systems for proper and smooth functioning of QC)

- Regulatory Compliance (Ensure compliance for all technical deliverables, audits, Measures for elimination of potential noncompliance. Answer & provide clarity on Audit queries. )

- Resource management, scheduling activities & Planning (Ensue 100% online documentation. Timely release of batches/ packing materials.

- Release of RM/PM/batches Material specifications (Timely release of materials, batches in coordination with requirement of manufacturing plan )

- Stability (Timely completion and reporting of stability studies. Monitoring /Review of stability /data )

- Microbiology (Control of Laboratory systems and microbiological processes. )

- Team Management (Manage team size – 30, Levels : Manager to Freshers. Ensure that team is motivated and encouraged at all times. Control attrition levels. )

- Training and development (Train the entry level and junior employees wrt Good Laboratory Practices.)