- Education: B.Sc./M.Sc. (Chemistry/Analytical Chemistry) or B.Pharm / M.Pharm from a recognized university.
- Experience: Minimum 8–10 years of hands-on experience in pharmaceutical Quality Control, with a strong background in capsulation (soft gelatin/hard gelatin) testing.
- Regulatory Approval: Must be an FDA-approved competent technical staff member for chemical and instrumental analysis under the Drugs and Cosmetics Rules.
- Release and Rejection: Hold the final authority to approve or reject raw materials, packaging materials, intermediate, bulk, and finished capsulation products based on analytical findings.
- Specification Management: Ensure that all analytical testing is conducted strictly according to current pharmacopoeial monographs (IP/BP/USP) or validated in-house specifications.
- GLP & WHO-GMP Compliance: Implement and maintain Good Laboratory Practices (GLP) ensuring complete alignment with WHO-GMP and the revised CDSCO Schedule M requirements.
- Data Integrity: Enforce strict ALCOA+ principles across all laboratory documentation, ensuring all analytical raw data, chromatograms, and logs are accurate, contemporaneous, and securely archived.
- Laboratory Operations & Equipment Management
- Analytical Review: Review and approve Analytical Test Reports (ATR), QC protocols, standard testing procedures (STPs), and certificates of analysis (COA) before product release.
- Calibration & Maintenance: Oversee the master calibration schedule and routine maintenance of all analytical instruments (e.g., HPLC, GC, Dissolution Testers, UV-Vis Spectrophotometers, FTIR).
- Reference Standards: Supervise the procurement, characterization, storage, and usage of Working Standards, Reference Standards (like IPRS), and microbial cultures.
- Method Validation: Review and approve analytical method validation and transfer protocols, specifically for complex formulations, multi-mineral/vitamin blends, and specific capsule delivery systems.
Pay: ₹25,000.00 - ₹30,000.00 per month
Benefits:
Work Location: In person
