Drug Testing Quality Systems Lead

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 :

How to Apply

Interested candidates may contact us or share their updated resume at the following email addresses :

📧 talentacquisition@efrac.org / sangiita.sheet@efrac.org

📞 Contact : +91 62922 79952

While applying, please mention “Application for QC Manager – Pharma Testing Laboratory” in the subject line.

Kindly include the following details along with your resume :