Quality Control Manager(Drug Lab)
1 week ago
QC Manager – Drug / Pharmaceutical Testing LaboratoryLocation: Kolkata (Barasat / New Town)Experience: Minimum 15 years in pharmaceutical or analytical testing laboratoriesPosition Summary:Edward Food Research & Analysis Centre Ltd. (EFRAC) is seeking an accomplished Quality Control (QC) Manager to lead and oversee the Quality Control operations of its Drug / Pharmaceutical Testing Laboratory. The incumbent will be responsible for ensuring analytical accuracy, regulatory compliance, and adherence to ISO/IEC 17025, GLP, NABL, and CDSCO guidelines. This role involves managing method validation, instrument performance (HPLC, GC-MS/MS, LC-MS/MS, ICP-MS), data integrity, and overall quality systems within the laboratory.Key Responsibilities:- Lead, mentor, and manage the QC team to ensure high-quality analytical outputs. - Review analytical data, manage Out of Specification (OOS) / Out of Trend (OOT) results, and implement Corrective and Preventive Actions (CAPA). - Oversee and maintain laboratory documentation, including SOPs, method validation records, calibration logs, and test reports. - Ensure full compliance with ISO/IEC 17025, NABL accreditation standards, and applicable drug regulatory guidelines (CDSCO, GLP, etc.). - Drive continual improvement initiatives in laboratory processes, data management, and quality systems. - Coordinate effectively with QA, R&D, and other cross-functional teams for smooth laboratory operations and audit preparedness. - Plan and conduct internal audits and facilitate external regulatory or client audits. - Train and develop staff to enhance technical expertise, regulatory awareness, and quality culture across the QC function. - Monitor the performance and calibration of key analytical instruments (HPLC, GC-MS/MS, LC-MS/MS, ICP-MS, etc.).Candidate Profile:- Education: B.Sc. / M.Sc. in Chemistry, Biotechnology, Pharmaceutical Sciences, or B.Pharm / M.Pharm. - Experience: Minimum 15 years of hands-on and managerial experience in pharmaceutical or analytical testing laboratories. - Technical Expertise: Strong knowledge of analytical instrumentation, method validation, and regulatory audit management. - Leadership Skills: Proven track record of leading QC teams, managing compliance systems, and fostering a culture of quality and continuous improvement. - Soft Skills: Excellent communication, analytical thinking, and problem-solving abilities. - Relocation: Candidates must be willing and comfortable to relocate to Kolkata (Barasat )How to ApplyInterested candidates may contact us or share their updated resume at the following email addresses:talentacquisition@efrac.org / sangiita.sheet@efrac.orgContact: +91 62922 79952While applying, please mention “Application for QC Manager – Pharma Testing Laboratory” in the subject line.Kindly include the following details along with your resume:- Total Experience: - Current CTC: - Expected CTC: - Notice Period:
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