Quality Control Manager(Drug Lab)
QIMA
5 - 10 years
Kolkata
Posted: 10/12/2025
Job Description
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:
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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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