Job description
Key Responsibilities
- Testing & Analysis Perform chemical, physical, and instrumental analysis of raw materials, intermediates, finished products, and packaging components. Operate analytical instruments such as HPLC, GC, UV-Vis spectrophotometer, FTIR, dissolution apparatus, and KF titrator. Conduct water analysis (RO, Purified Water, WFI) as per pharmacopeial requirements. Support stability studies by testing stability samples as per protocol.
- Documentation & Compliance Record all observations and results in relevant formats as per GDP (Good Documentation Practices). Prepare and review test records, specifications, and SOPs. Maintain laboratory logbooks, instrument usage records, and calibration records. Ensure all activities comply with cGMP, WHO GMP, and regulatory guidelines.
- Equipment Handling & Calibration Ensure proper operation, cleaning, and calibration of laboratory instruments. Participate in qualification of laboratory instruments and equipment.
- Audit & Regulatory Support Assist during internal, customer, and regulatory inspections by presenting test records and data. Participate in root cause investigations and CAPA implementation for OOS, OOT, or deviations.
- Coordination Liaise with QA, Production, and R&D teams to resolve quality-related issues. Coordinate with stability and microbiology teams for testing requirements.