The Quality Control (QC) Manager oversees all laboratory testing activities to ensure that raw materials, in-process samples, finished products, and stability samples meet internal specifications and comply with regulatory standards. This role ensures compliance with c GMP, company SOPs, and applicable regulatory requirements (e.g., FDA, EMA, WHO). The QC Manager leads and develops the QC team, manages laboratory resources, and drives continuous improvement in quality operations.

Responsibilities
Laboratory Oversight Manage daily operations of the QC laboratory (chemical, physical, and microbiological testing). Ensure timely and accurate analysis of raw materials, intermediates, finished products, and stability samples.
Compliance and Documentation Ensure full compliance with c GMP, GLP, and relevant regulatory guidelines. Review and approve laboratory data, test results, CoAs, and protocols. Maintain and audit QC documentation, ensuring data integrity and traceability.
Team Leadership and Development Lead, train, and mentor QC analysts and technicians. Evaluate staff performance and ensure continuous development and cross-training.
Method Validation & Transfer Coordinate method validation, verification, and transfers in collaboration with R&D and QA. Support new product introductions and scale-ups from a QC perspective.
Laboratory Equipment Management Oversee calibration, maintenance, qualification, and lifecycle management of lab instruments. Approve equipment qualification protocols and reports.
Investigation & Change Control Lead OOS, OOT, deviations, CAPA, and laboratory investigations. Support change control related to testing methods, materials, and specifications.
Audit Readiness and Support Ensure QC area is inspection-ready at all times. Act as SME during internal, customer, and regulatory audits.
Continuous Improvement Identify and implement process improvements to enhance efficiency, accuracy, and compliance.
Qualifications
Bachelor’s or Master’s degree in Pharmacy. Minimum of 7–10 years of experience in a pharmaceutical QC environment, including at least 3 years in a leadership role. Deep understanding of c GMP, and regulatory expectations. Strong leadership, problem-solving, and communication skills.