Job Purpose:
To perform raw material, in-process, and finished product analysis using validated analytical techniques, ensuring compliance with GMP/GLP guidelines and regulatory requirements.
Key Responsibilities:
- Perform analysis of raw materials, in-process samples, and finished products as per approved specifications, test methods, and protocols.
- Operate, calibrate, and maintain analytical instruments including HPLC, FTIR, and GC.
- Troubleshoot analytical instruments, particularly HPLC systems, and ensure uninterrupted laboratory operations.
- Ensure proper documentation and data integrity in compliance with GMP and GLP guidelines.
- Maintain and update laboratory records, test reports, calibration records, logbooks, and analytical worksheets.
- Utilize server-based chromatography software for data acquisition, processing, and reporting for HPLC and GC systems.
- Ensure compliance with Good Documentation Practices (GDP) at all times.
- Coordinate with QA for out-of-specification (OOS) investigations, deviations, and corrective actions when required.
- Ensure proper handling, labeling, storage, and disposal of samples and chemicals.
- Support internal and external audits by providing required documentation and technical explanations.
Technical Skills & Knowledge:
- Strong operating knowledge of HPLC, FTIR, and GC instruments.
- Hands-on experience in calibration, operation, and troubleshooting of HPLC systems.
- Knowledge of SAP for material management, data entry, or quality-related transactions.
- Proficiency in MS Office applications (Word, Excel, PowerPoint).
- Experience working with server-based chromatography software for HPLC and GC.
- Understanding of GMP, GLP, GDP, and regulatory compliance requirements.
Educational Qualification:
- B.Sc / M.Sc in Chemistry / Analytical Chemistry / Pharmaceutical Sciences or equivalent.
Experience:
- 14 years of relevant experience in a QC laboratory within pharmaceutical / medical device / chemical manufacturing industries.
