Asst - Quality Assurance Manager (API)

Job Description

Job Description Asst Manager – Quality Assurance

Key Responsibilities:

Preparation, review and approval of SOPs, specifications, test methods and quality documents.
Implementation and monitoring of QMS, cGMP, GLP and regulatory compliance (including DMF).
Batch record review and authorization of product release or rejection.
Handling deviations, OOS/OOT, market complaints and ensuring effective CAPA.
Control of change management and impact assessment.
Qualification & validation of equipment, utilities and processes as per VMP.
Calibration oversight and monitoring of temperature, humidity and critical records.
Conducting internal audits, vendor audits and handling external/regulatory audits.
Coordination with Production, QC and other departments for quality performance review.
Stability study coordination and regulatory/customer query responses.
Training coordination and recruitment of QA staff.
Ensuring plant compliance related to Safety, Health & Hygiene.
Weekly plant status review and reporting to management.
Any additional responsibilities assigned by management.