Primary Purpose: Ensure manufactured products meet strict quality, safety, and purity standards by testing raw materials, in-process samples, and finished goods against established specifications and regulatory guidelines, acting as the gatekeeper to prevent substandard products from reaching consumers and ensuring consistency across batches.
Key Accountabilities:Conduct quantitative and qualitative tests on raw materials, intermediates, and final products for identity, purity, potency, and stability. Utilize and maintain sophisticated lab equipment like HPLC, GC, UV/Vis Spectrophotometers, etc., ensuring calibration and validation. Develop, perform, and document method validation and verification studies. Accurately record all test data, review results, and generate reports for stakeholders. Ensure all activities comply with c GMP, GLP, and other relevant guidelines. Participate in internal and external audits and inspections. Investigate and resolve out-of-specification (OOS) or non-conforming results. Collaborate cross-functionally (Manufacturing, R&D, QA) to implement Corrective and Preventive Actions (CAPA). Identify opportunities for continuous quality improvement. Prepare and standardize reagents and standards. Maintain laboratory cleanliness, manage waste, and ensure a safe working environment. Operating, calibrating, and maintaining laboratory equipment like HPLC, GC, and spectrophotometers. Maintaining a safe and organized laboratory environment by following safety protocols and waste disposal procedures. Potentially training junior staff on techniques and procedures.
Education:A Bachelor Degree in Science or Chemical engineering.