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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