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