COLOGENESIS HEALTHCARE

ColoGenesis Healthcare Pvt Ltd Pay: From ₹35,000.00 per month Job description: Key Responsibilities: Lead and oversee all QC activities, including RM, Bulk Product (BP), Finished Product (FP), Packaging Material, Stability and Environmental Monitoring. Ensuring timely sampling, testing, review, and release of materials and products as per approved specifications. · 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 (HPLC, balances, incubators, etc.) · Train and mentor QC team to maintain accuracy, compliance, and data integrity. · Handle deviations, OOS/OOT investigations, and implement CAPA. · Ensure compliance with GMP, GLP, ISO 13485, MDR-2017 and applicable regulatory requirements and documenting the same. · Prepare, review, and control QC documents (SOPs, protocols, reports, records). · Approve test protocols and reports; ensure proper record keeping. · Plan and utilise manpower, equipment, and consumables effectively. · Oversee method validation, verification, and transfer for chemical and microbiological tests. Design, review, and approve stability protocols and evaluate stability data. Coordinate with QA and Production departments to resolve analytical and process issues. Drive continuous improvement initiatives in testing efficiency, cost optimisation and compliance 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.