17 Sep
|
Vision Medichem
|
India
17 Sep
Vision Medichem
India
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 Positive Manufacturing Practices) and GLP (Positive 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.
Robust 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
📌 Quality Control In Charge Ojhar (India)
🏢 Vision Medichem
📍 India