Job Description

Location: Kolkata, Barasat

Experience: Typically 7–12 years

Function: Quality Assurance

Industry: Third-Party Testing / Analytical Laboratories


Read This First (Important)


This role is not for:

  • documentation coordinators
  • manufacturing-only QA profiles
  • QA professionals without audit ownership
  • candidates with no exposure to analytical testing environments


If your QA experience is limited to batch release, shop-floor GMP, or SOP maintenance , this role will not be suitable .


Role Summary


We are hiring a QA Manager to own and defend the Quality Management System for Food and Pharmaceutical testing laboratories .


This is a high-accountability, audit-facing role .

You will be expected to take technical QA positions during audits , challenge weak practices, and enforce compliance.


Who We Will Consider (Only These Two Profiles)


Profile 1 — Third-Party Testing Lab QA (Strongly Preferred)

You must have:

  • QA experience in Food and/or Pharma testing laboratories
  • Hands-on exposure to ISO/IEC 17025 (latest version)
  • Direct responsibility during NABL / regulatory audits
  • Practical experience with:
  • deviations, CAPA, change control
  • method validation oversight
  • data integrity investigations
  • audit observations and closures


Profile 2 — Strong Pharma QA (Selective Consideration)

You must have:

  • Solid Pharma QA experience beyond manufacturing supervision
  • Strong working knowledge of:
  • GLP, GDP, Data Integrity (ALCOA+)
  • deviation, OOS, CAPA, risk assessment
  • regulatory audits (USFDA / EMA / CDSCO)
  • Ability to translate Pharma QA rigor into an analytical testing lab environment


✔ Prior QC / analytical lab exposure is a strong advantage

⛔ Manufacturing-only QA with no GLP or analytical mindset will be rejected


Key Responsibilities (Non-Negotiable)

  • Full ownership of QMS for Food & Pharma testing laboratories
  • Lead NABL / regulatory audits end-to-end
  • Review and approve:
  • deviations, CAPA, change controls
  • validation summaries and risk assessments
  • data integrity investigations
  • Drive audit readiness and quality discipline
  • Train and challenge technical teams on compliance expectations
  • Act as the final QA authority , not a coordinator


Knowledge & Competency Expectations


You must be comfortable discussing and defending:

  • ISO/IEC 17025 interpretation
  • GLP & GDP application in labs
  • Data integrity lapses and remediation
  • Risk-based QA decision-making
  • Audit trail review (LC-MS/MS, HPLC, CDS)


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