Key Responsibilities1. Sample Analysis and Testing:Perform chemical and instrumental analysis of raw materials, intermediates, and finished API products according to approved specifications and Standard Testing Procedures (STPs).Conduct testing using a range of laboratory instruments, including but not limited to:High-Performance Liquid Chromatography (HPLC)Gas Chromatography (GC)Fourier-Transform Infrared (FT-IR) SpectroscopyUltraviolet-Visible (UV-Vis) SpectroscopyKarl Fischer TitratorAtomic Absorption (AA) Spectroscopy (if applicable)Perform wet chemistry techniques such as titrations, pH measurements, and various chemical assays.Analyze stability study samples as per protocol.2. Documentation and Record Keeping:Maintain accurate, detailed, and clear records of all tests performed, including raw data, calculations, and results, in laboratory notebooks and electronic systems.Ensure all data and records are compliant with cGMP and data integrity principles.Prepare Certificates of Analysis (CoAs) for finished products.Review and approve analytical data generated by junior staff, if applicable.Draft, review, and revise Standard Testing Procedures (STPs) and other QC-related documents.3. Equipment Management and Calibration:Perform routine calibration, qualification, and maintenance of laboratory instruments and equipment.Troubleshoot equipment issues and coordinate with service engineers for repairs as needed.Maintain a log of equipment usage, maintenance, and calibration records.Ensure all equipment is in a validated state and ready for use.4. Investigations and Quality Events:Investigate Out of Specification (OOS), Out of Trend (OOT), and other atypical results.Participate in root cause analysis (RCA) for quality events and assist in implementing Corrective and Preventive Actions (CAPA).Collaborate with the Quality Assurance (QA) and Production departments to resolve quality issues and support deviation investigations.5. Lab Compliance and Safety:Adhere to all laboratory safety protocols, including the use of appropriate Personal Protective Equipment (PPE) and proper handling of hazardous chemicals.Ensure the laboratory environment is clean, organized, and compliant with cGMP and good housekeeping practices.Participate in internal and external audits of the QC lab.Assist in the qualification and validation of new methods, equipment, and lab procedures.
