Officer/Executive

• *Role & responsibilities** • *Key Responsibilities** • *1. Finished Product Analysis** • Perform **chemical, physical, and instrumental analysis** of finished pharmaceutical products as per approved specifications. • Conduct tests such as: • Assay • General Bio test • Related substances • pH • Water content • Appearance, identification, and other pharmacopoeial tests • Follow **validated test methods** in compliance with **IP, BP, EP, and USP** where applicable. • *2. Documentation & Data Integrity** • Record test data accurately in: • Analytical worksheets • Laboratory notebooks • Laboratory Information Management System (LIMS), if applicable • Ensure compliance with **ALCOA+ principles** (Attributable, Legible, Contemporaneous, Original, Accurate, Complete). • Review and verify analytical data for accuracy and compliance. • *3. Instrument Handling** • Operate, maintain, and troubleshoot QC instruments such as: • HPLC / UPLC • UVVisible Spectrophotometer • Dissolution apparatus • FTIR • Karl Fischer • GC - • Ensure proper **instrument calibration, qualification, and logbook maintenance**. • *4. Compliance & Audits** • Adhere strictly to **EU GMP, MHRA, and internal SOPs**. • Actively support **regulatory inspections and customer audits**. • Participate in audit responses, data retrieval, and explanation of test procedures. • *5. OOS, OOT & Deviations** • Participate in: • **OOS (Out of Specification)** investigations • **OOT (Out of Trend)** evaluations • Deviations and CAPA activities • Assist in root cause analysis and implementation of corrective actions. • *6. Stability & Product Lifecycle Support** • Perform stability testing for finished products as per approved stability protocols. • Support **product release**, method transfers, and validation activities as required. • Assist in **method verification and method validation** when assigned. • *7. EHS & GMP Culture** • Comply with **EHS, GMP, and data integrity policies** at all times. • Maintain cleanliness and discipline in the laboratory as per GMP requirements. • *Preferred candidate profile** Only candidates currently working in the pharmaceutical industry may apply