Quality Control Manager

Key Responsibilities:

• Lead and manage the QC department including Analysts, microbiologists, and lab technicians.

• Oversee analytical testing for raw materials, in-process samples, finished products, and stability studies.

• Approve release decisions for batches in accordance with specifications and SOPs.

• Maintain compliance with cGMP/cGLP, PIC/S guidelines and local regulatory requirements.

• Develop and implement QC SOPs, test methods, and validation programs. Support best practices in Laboratory in terms of integrity, accuracy and adequacy of the testing and documentation.

• Manage laboratory quality systems: deviation handling, CAPA, change control, OOS/OOT investigations, and documentation control.

• Coordinate regulatory inspections and supplier audits; prepare QC for site visits and responses.

• Drive continuous improvement in test turnaround time, cost control, and method robustness....