Manager – Quality Assurance

Job Description

GMP Compliance – Drug Product Facility
•    Monitor day-to-day activities and plan allocation of IPQA personnel as per batch schedule. Oversee critical manufacturing activities including dispensing, in-process checks, sampling, filling, sealing, visual inspection, and AQL.
•    Coordinate with Drug Product (DP) teams for smooth batch execution from dispensing to dispatch.
Review technical documents related to drug product manufacturing.
Media Fill, Validation, and Qualification
•    Review media fill protocols and reports in compliance with current regulatory guidelines. Ensure equipment and area qualifications, including periodic requalification for drug product facilities.
•    Review process validation and cleaning validation protocols and reports.
Ensure availability of visual inspection qualification kits.
Contract Manufacturing Organizations (CMOs) Activities
•    Ensure manufacturing and analytical activities at CMOs are conducted in compliance with Quality Technical Agreements and cGMP requirements.
•    Coordinate and communicate with CMO manufacturing and analytical teams for timely execution and tracking of activities.
•    Identify the need for new procedures and ensure their implementation; perform gap analysis of existing procedures.
•    Review executed Batch Processing Records (BPR) and Analytical Records (AR) for batch release, and coordinate with CMOs to ensure compliance.
•    Review and approve Annual Product Quality Review (APQR) reports for products manufactured at CMOs.
Market Complaint and Recall Activities
•    Manage market complaints including registration, communication with complainants and DSRM, investigation, and implementation of corrective and preventive actions (CAPA).
•    Notify stakeholders regarding product or batch recalls/market withdrawals.

Work Experience

10-15 Years of relevant work experience in Biopharma

Education

Competencies