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

General Manager – Quality Assurance (Solid Oral Facility)