A Fresh Pharmacist in the Quality Control (QC) Laboratory is responsible for performing routine analytical testing of raw materials, in process samples, finished pharmaceutical products, and stability samples to ensure they meet established quality standards. The role involves strict adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and standard operating procedures (SOPs) to support the production of safe, effective, and high-quality pharmaceutical products.
Key Responsibilities
1. Analytical Testing & Documentation
- Perform physical, chemical, and instrumental analysis of samples using techniques such as salt analysis, pH and conductivity testing of water and infusion according to SOPs.
- Prepare reagents, standards, and samples for analysis as per approved procedures.
- Accurately record analytical data in laboratory notebooks, worksheets, and electronic systems.
- Ensure all laboratory documentation is complete, accurate, and properly maintained.
2. Compliance & Quality Systems
- Follow approved SOPs, analytical methods, and pharmaceutical standards (USP, EP, IP, BP).
- Adhere to GMP, GLP, and laboratory safety guidelines at all times.
- Assist in laboratory investigations related to Out of Specification (OOS), Out of Trend (OOT), and deviations.
3. Instrumentation & Maintenance
- Operate laboratory instruments and ensure they remain in calibrated and validated condition.
- Perform basic troubleshooting and report instrument malfunctions to supervisors.
- Maintain cleanliness, organization, and proper housekeeping of the laboratory work area.
4. Sampling & Storage
- Collect and handle raw materials, packaging materials, and finished product samples according to SOPs.
- Ensure proper labeling, handling, and storage of retained samples and reference standards.
5. Reporting & Communication
- Report analytical results to the QC Supervisor/Manager in a timely manner.
- Immediately communicate any abnormalities, discrepancies, or non-conformities.
- Assist in preparing Certificates of Analysis (CoA) under supervision.
6. Continuous Improvement & Training
- Participate in training programs related to analytical techniques, SOPs, and safety practices.
- Support method verification and validation activities when required.
- Contribute to continuous improvement and efficiency of laboratory processes.