Job Purpose
To lead Quality Assurance operations for the Solid Oral facility and ensure compliance with cGMP, global regulatory requirements, data integrity standards, and Quality Management Systems.
Key Responsibilities
- Ensure compliance with cGMP, Data Integrity, and global regulatory requirements including USFDA, WHO-GMP, EU GMP, MHRA, PIC/S, TGA, and ANVISA.
- Lead Quality Management System (QMS) activities including deviations, OOS, CAPA, change control, market complaints, and investigations.
- Oversee batch review, approval, and release activities.
- Ensure qualification and validation of processes, equipment, utilities, cleaning, and computerized systems.
- Manage vendor qualification, quality agreements, artwork approvals, and risk assessments.
- Lead internal audits, self-inspections, customer audits, and regulatory inspections.
- Coordinate with Production, QC, Warehouse, Engineering, Regulatory Affairs, and Tech Transfer teams for compliance and operational support.
- Provide quality oversight for technology transfer, product development, and commercialization activities.
- Ensure SOP compliance, training effectiveness, and continuous improvement of quality systems.
- Monitor regulatory updates and implement required quality compliance changes.
- Lead and develop QA/QC teams through effective training, mentoring, and performance management.
- Manage departmental resources, budgeting, and manpower planning.
Qualifications
- M.Pharm / B.Pharm / MSc or equivalent in Pharmaceutical Sciences.
Experience
- 18–25 years of experience in QA/QC within pharmaceutical manufacturing, preferably in Solid Oral Dosage facilities with exposure to global regulatory audits.
Key Skills
- Quality Management Systems (QMS)
- Regulatory Compliance & Audit Handling
- Data Integrity & cGMP
- Investigation & CAPA Management
- Validation & Qualification
- Leadership & Team Management
- Risk Assessment & Change Control
- Cross-functional Coordination
