Executive-Quality Control Department

Prepare, review, approve, and implement Quality Control (QC) documents, including Standard Operating Procedures (SOPs), specifications, test methods, and analytical procedures for raw materials, packaging materials, in-process materials, finished products, and laboratory operations.

Supervise and monitor daily QC activities, assign responsibilities to QC Officers, provide necessary technical guidance, and ensure timely and accurate completion of all assigned tasks.

Review and evaluate analytical test results against approved specifications and ensure appropriate decisions regarding sample acceptance, rejection, or retesting in compliance with established procedures.

Ensure proper implementation of analytical method validation, method verification, and method transfer programs. Develop and validate cost-effective analytical methods where applicable.

Ensure proper testing and analysis of incoming raw materials, packaging materials, in-process materials, finished products, and stability samples in accordance with approved specifications and regulatory requirements.

Investigate Out of Specification (OOS), Out of Trend (OOT) results, deviations, and other laboratory-related incidents, and ensure appropriate corrective and preventive actions (CAPA).

Provide technical training and guidance to QC personnel on analytical techniques, laboratory procedures, GMP, GLP, and other relevant quality control practices.

Ensure proper calibration, qualification, maintenance, and periodic verification of QC laboratory instruments and equipment according to approved schedules.

Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), laboratory safety requirements, and proper housekeeping standards within the QC laboratory.

Monitor laboratory documentation, data integrity, analytical records, and reporting systems to ensure accuracy, traceability, and regulatory compliance.

Coordinate with Production, QA, R&D, and other relevant departments to resolve quality-related issues and ensure consistent product quality.

Participate in internal and external audits, regulatory inspections, quality investigations, and implementation of corrective and preventive actions.

Evaluate the performance of QC personnel, identify training needs, and ensure continuous improvement in departmental efficiency and technical capabilities.

Develop and implement strategies to improve laboratory efficiency, reduce testing turnaround time, optimize resource utilization, and minimize analytical costs without compromising quality standards.

Ensure that all QC activities are conducted in accordance with applicable pharmaceutical regulations, approved quality standards, and company policies.