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Pharmaceutical Quality Assurance Manager

Pharmaceutical Quality Assurance Manager

QIMAKolkata, Republic Of India, IN
10 days ago
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 :

    📧 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 :

  • Total Experience :
  • Current CTC :
  • Expected CTC :
  • Notice Period :
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    Quality Assurance Manager • Kolkata, Republic Of India, IN

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