QC Executive
- Silvassa, Dadra & Nagar Haveli
- Permanent
- Full-time
- Analytical Testing:
- Perform routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples using HPLC, GC, UV, IR, etc.
- Conduct assay, dissolution, impurity profiling, and related substance testing as per pharmacopeial standards (USP, BP, IP, etc.).
- Instrument Operation & Calibration:
- Operate and maintain analytical instruments (HPLC, GC, UV-Vis Spectrophotometer, FTIR) efficiently.
- Perform daily calibration and verification of laboratory instruments as per SOPs.
- Documentation & Compliance:
- Ensure timely and accurate documentation of all analytical data as per ALCOA+ principles.
- Maintain logbooks, test reports, and worksheets in compliance with GLP and GDP.
- Review analytical results and report any OOS (Out of Specification) or OOT (Out of Trend) results to the supervisor immediately.
- Regulatory & Quality Systems:
- Ensure compliance with cGMP, GLP, and regulatory requirements (e.g., USFDA, MHRA, WHO).
- Participate in internal audits, regulatory inspections, and CAPA implementations.
- Sample Management:
- Ensure proper handling, storage, labeling, and disposal of samples.
- Maintain traceability of samples and reagents throughout the testing process.
- Continuous Improvement:
- Participate in method validation, method transfer, and process improvement initiatives.
- Assist in troubleshooting analytical methods and equipment-related issues.
- Strong documentation skills; understanding of ALCOA+ principles.
- Good understanding of analytical chemistry and pharmacopeial methods.
- Strong attention to detail and organizational skills.