15h Left: Qc Manager

4 weeks ago


Salem, Tamil Nadu, India Cologenesis Healthcare Pvt Ltd 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 Paid sick time Paid time off Experience hr 2 years Preferred HR sourcing 1 year Required Language English Required Work Location In person


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