Key Responsibilities & Duties
- Laboratory Operations Management:
- Oversee daily testing schedules for raw materials, packaging materials, in-process samples, and finished products.
- Ensure compliance with cGMP (Current Good Manufacturing Practices) and GLP (Good Laboratory Practices) inside the lab.
- Testing & Validation:
- Review and approve analytical test data, chromatograms (HPLC/GC), and Certificates of Analysis (CoA).
- Supervise method validations, instrument calibrations, and analyst qualifications.
- Investigations & Compliance:
- Investigate OOS (Out-of-Specification) and OOT (Out-of-Trend) results, deviations, and laboratory incidents.
- Implement CAPA (Corrective and Preventive Action) plans for identified lab issues.
- Audit Readiness:
- Maintain audit-ready lab documentation, logbooks, and Standard Operating Procedures (SOPs).
- Face regulatory inspections (e.g., USFDA, MHRA, CDSCO) for the QC domain.
Required Qualifications & Skills
- Education:
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) or Post-Graduation in Chemistry (M.Sc).
- Experience:
- Minimum 5 to 8 years of pharmaceutical QC experience, with at least 2–3 years in a supervisory or in-charge role.
- Technical Skills:
- Hands-on expertise with advanced analytical instruments like HPLC, GC, UV-Spectrophotometer, and dissolution apparatus.
- Strong knowledge of pharmacopeial standards (IP, USP, BP).
- Core Competencies:
- People management, data integrity awareness (ALCOA+ principles), problem-solving, and cross-functional coordination with Production and Quality Assurance (QA).
Pay: ₹8,838.73 - ₹46,451.57 per month
Work Location: In person
