Posted:1 day ago|
Platform:
On-site
Full Time
Key Responsibilities:
· Lead and manage QC operations for raw materials, in-process, and finished products.
· Oversee analytical testing methods: HPLC, UV Spectrophotometer, Kjeldahl, KF Titrator, SDS-PAGE, Hydroxyproline test, Protein content analysis.
· Review and approve COAs, protocols, and reports in compliance with GMP, ISO 13485, and 21 CFR Part 11.
· Ensure calibration and preventive maintenance of QC instruments.
· Train and mentor QC team to maintain accuracy, compliance, and data integrity.
· Handle deviations, OOS/OOT investigations, and implement CAPA.
· Ensure audit readiness and regulatory compliance at all times.
· Prepare, review, and control QC documents (SOPs, protocols, reports, records).
· Approve test protocols and reports; ensure proper record keeping.
· Plan and utilize manpower, equipment, and consumables effectively.
· Oversee method validation, verification, and transfer for chemical and microbiological tests.
Qualifications & Experience:
· M.Sc. (Chemistry / Biochemistry) or B.Pharm / M.Pharm.
· 5-8 years of QC experience in pharmaceuticals / medical devices / biotech,
· Strong knowledge of analytical techniques and regulatory requirements.
· Experience in handling customer and regulatory audits preferred.
Job Type: Full-time
Pay: From ₹35,000.00 per month
Benefits:
Experience:
Language:
Work Location: In person
Cologenesis Healthcare Pvt Ltd
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