Job Responsibilities:

To guide and train IPQA Persons to develop expertise, evaluate their skills and review training reports to ensure that they are well-prepared and qualified for their respective roles.
To develop and implement a system for reporting IPQA persons.
Lead the investigation of quality incidents, deviation, OOS/OOT and non-conformances. Ensure root cause analysis and implementation of corrective action and preventive action (CAPA) and monitor the effectiveness of CAPAs and report outcomes.
To ensure that Batch record and batch analytical documents are filled online and reviewed before dispatch of products.
To review and approve specifications and STP.
To review / Approval / Control/monitor quality control-related activity and documents including SOP’s, protocol and report.
Prepare and maintain the facility for internal and external regulatory inspection and audits.
Lead and participate in mock audits to identify and address potential compliance gaps.




Collaborate with cross-functional teams to ensure adherence to QMS processes and provide support during regulatory inspections.
Participate in quality improvement initiatives, identify opportunities to streamline processes and ensure the facility adopts best practices.
To perform GMP round in all departments like production, QC, Micro, Warehouse, Engineering and report abnormal observation.
To review the monthly report like stability study report, RD study report, FP retain sample report and hold time study report.
If any abnormality observed in stability study report, RD study report, FP retain sample report carry out investigation and suggest suitable CAPA for the same.

Candidate Criteria: –

Education: M.Sc. / B. Pharm / M. Pharm

Experience: Having 8 to 12 years in Formulation Pharmaceutical.

📌 Assistant QA Manager (India)
🏢 MERIDIAN ENTERPRISES
📍 India