Quality Control Manager(Drug Lab)

2 days ago

Kolkatta, India QIMA Full time

QC Manager – Drug / Pharmaceutical Testing Laboratory Location: Kolkata (Barasat / New Town) Experience: Minimum 15 years in pharmaceutical or analytical testing laboratories Position 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 Apply Interested candidates may contact us or share their updated resume at the following email addresses: / Contact: While 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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