Manager / Senior Manager – Quality Assurance (QA)

Location: EFRAC, Kolkata

Department: Quality Assurance

Experience: Minimum 10–18 years in QA roles within ISO/IEC 17025 accredited labs; experience in USFDA-approved pharma or GMP environment strongly preferred.

Role Summary

The QA Manager / Sr. Manager will lead all quality assurance activities across EFRAC’s Food, Pharmaceutical and Environmental laboratories. This includes maintaining ISO/IEC 17025 and ISO/IEC 17043 accreditations, ensuring compliance with USFDA expectations on data integrity and laboratory systems, driving audit readiness, and strengthening the overall quality culture in the organisation. The role requires deep technical understanding of lab operations, QA systems, documentation, method compliance, and regulatory frameworks.

Key Responsibilities

1. Quality Management System (QMS) Ownership

• Oversee the implementation, maintenance and continuous improvement of the QMS as per ISO/IEC 17025 and ISO 17043.
• Ensure all procedures, records, manuals, quality policies and risk assessments meet accreditation and regulatory requirements.
• Review and approve controlled documents, SOPs, test methods, work instructions and operational templates.
• Ensure effective document control, internal reviews and version management.

2. Audit Management (External & Internal)

• Lead all external audits: NABL, ISO 17043, FSSAI, EIC, APEDA, CPCB, WBPCB, and client audits.
• Support teams for USFDA-aligned audit requirements including ALCOA+, data integrity, system suitability checks, audit trails, and instrument compliance.
• Prepare audit dossiers and ensure labs remain audit-ready at all times.
• Coordinate CAPA responses, root-cause analyses, and timely closure of non-conformities.

3. Data Integrity & Compliance

• Implement and monitor ALCOA+ principles across all analytical workflows.
• Oversee data integrity practices across instruments, LIMS entries, raw data, chromatograms, microbiology records and manual forms.
• Ensure secure, traceable and compliant documentation and record-keeping systems.
• Drive periodic data audits and integrity checks.

4. Method & Technical Quality Oversight

• Review validation, verification and uncertainty data for compliance and accuracy.
• Ensure adherence to approved test methods and regulatory protocols.

* Support PT/ILC participation, evaluation of Z-scores, and lead corrective actions.

* Guide labs in trending, control charting and performance monitoring.

5. Internal Quality Activities

• Plan and execute internal audits, system audits, housekeeping audits, and safety assessments.
• Own the proficiency testing (PT) QA process under ISO 17043 including documentation, review of homogeneity/stability data and statistical assessments.
• Oversee calibration and maintenance compliance across all instruments.
• Ensure preventive quality actions are implemented across labs.

6. Training & Quality Culture

• Train staff across all levels on QMS, GMP, documentation, data integrity, incident handling and audit readiness.
• Conduct competency assessments and monitor analyst performance improvement.
• Build a strong quality mindset and discipline across operational teams.

7. Regulatory Submissions & Approvals

• Manage accreditation renewals, scope extensions and regulatory submissions.
• Coordinate with departments for preparing technical files, management review data and compliance reports.
• Ensure timely submission of documents to NABL and other regulatory bodies.

Qualifications

• M.Sc / M.Tech in Chemistry, Microbiology, Biotechnology or relevant field.
• 10–18 years of QA experience in accredited laboratories.
• Strong working knowledge of ISO/IEC 17025:2017 and ISO/IEC 17043:2010.
• Experience in USFDA-approved pharma facilities or GMP environments strongly preferred.
• Hands-on experience with audits, data integrity, CAPA systems, and QMS implementation.

Key Skills & Attributes

• Strong leadership and decision-making ability.
• High attention to detail and documentation discipline.
• Excellent understanding of analytical workflows and technical requirements.
• Ability to work calmly under audit pressure.
• Strong communication and training capability.
• Ability to influence teams and drive compliance.