Assistant Manager - Quality Assurance

Role & responsibilities

QMS & GMP Compliance, Deviations, OOS/OOT & CAPA, Change Control Management, Market Complaints, Root Cause Analysis, Risk Assessment

Preferred candidate profile

• Management of Quality Management System (QMS) activities.
• Review and approval of Deviations, OOS, OOT, and Incident investigations.
• CAPA initiation, effectiveness verification, and lifecycle management.
• Change Control assessment, review, and implementation.
• Handling and investigation of Market Complaints and Product Quality Complaints.
• Preparation, review, and approval of SOPs, specifications, protocols, and reports.
• Internal audits, self-inspections, and compliance monitoring.
• Vendor qualification and quality agreement management.
• Quality Risk Management (QRM) using tools such as FMEA and risk assessment matrices.
• Management Review meetings and quality metrics trending.
• Regulatory inspection readiness and response management.
• Data integrity compliance and GMP documentation review.
• Training management and effectiveness evaluation.
• Support for product quality reviews (PQR/APQR).
• Continuous improvement initiatives and quality culture enhancement.