- 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 Positive 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

- Provident Fund

Work Location: In person

📌 Quality Control Incharge (Kanpur)
🏢 Jyoti Capsulations Private
📍 Kanpur