Job Summary
Role: Quality Control Officer (Pharma)
Location: Ankleshwar GIDC / Panoli, Gujarat
Key Goal: To perform analytical testing and ensure 100% compliance with GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices).
Key Responsibilities
1. Analytical Testing & Analysis
- Sample Testing: Conduct routine analysis of raw materials, in-process samples, stability samples, and finished pharmaceutical products (APIs or Formulations).
- Instrument Operation: Hands-on operation of advanced analytical instruments such as:
- HPLC (High-Performance Liquid Chromatography)
- GC (Gas Chromatography)
- UV-Visible Spectrophotometers
- FTIR (Fourier-transform infrared spectroscopy)
- Wet Chemistry: Perform basic lab tests including Titration, pH measurement, viscosity, and dissolution testing.
2. Documentation & Compliance
- Record Keeping: Maintain accurate, real-time documentation of all test results in Lab Notebooks or LIMS (Laboratory Information Management System).
- COA Preparation: Prepare and review Certificates of Analysis (COA) for batch release.
- SOP Adherence: Strictly follow Standard Operating Procedures (SOPs) to ensure regulatory compliance (FDA, WHO-GMP, etc.).
3. Quality Assurance & Investigations
- OOS/OOT Investigations: Participate in investigations for Out of Specification (OOS) or Out of Trend (OOT) results to identify root causes.
- Calibration: Perform daily and periodic calibration of lab instruments to ensure data integrity.
- Method Validation: Assist in the validation and transfer of analytical methods from R&D to the QC lab.
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