Deputy Manager, Quality Assurance

Job Responsibilities

• Lead and manage the overall Quality Assurance (QA) function of the pharmaceutical manufacturing facility.
• Ensure compliance with GMP, cGMP, WHO-GMP, GLP, and applicable regulatory requirements.
• Develop, implement, and continuously improve the company’s Quality Management System (QMS).
• Review and approve SOPs, specifications, protocols, reports and other quality documents.
• Ensure proper handling, investigation, and closure of deviations, OOS/OOT, CAPA, Change Control, and Market Complaints.
• Supervise and ensure proper execution of Batch Record review and Batch Release activities.
• Coordinate and lead internal, external, regulatory and customer audits/inspections.
• Ensure proper implementation of Self-Inspection, Quality Risk Management, and Continuous Improvement programs.
• Review and approve Validation/Qualification protocols and reports in coordination with relevant departments.
• Ensure proper documentation, data integrity, and compliance with established quality procedures.
• Monitor manufacturing and packaging operations to ensure compliance with approved procedures and GMP requirements.
• Provide guidance and leadership to QA personnel and develop the team through training and performance management.
• Coordinate effectively with Production, Quality Control, Engineering, Regulatory Affairs, Warehouse, and other relevant departments.
• Identify potential quality risks and implement appropriate preventive and corrective measures.
• Keep management updated regarding significant quality issues, compliance risks, and improvement initiatives.
• Perform any other duties assigned by the management related to Quality Assurance and regulatory compliance.

Job Requirements

Education

• Master of Pharmacy (M.Pharm)

Experience

• At least 10 years in QA in Pharmaceutical Companies