Manager, Quality Assurance Department

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.