- 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 cGMP, 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.
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 cGMP, and regulatory expectations.Strong leadership, problem-solving, and communication skills.