Zentiva Opening for Quality Assurance Specialist at Ankleshwar

Zentiva is hiring an experienced pharmaceutical professional for the role of Quality Assurance Specialist within its QA division at the Ankleshwar manufacturing site. The role focuses on Good Distribution Practice (GDP) compliance, Wholesale Distribution Authorisation (WDA) maintenance, and quality management systems across commercial distribution channels.

Role Overview & Key Responsibilities

WDA & GDP Compliance: Support maintenance of the Dutch WDA license in coordination with the external Responsible Person (RP) service provider; maintain complete, inspection-ready WDA documentation and monitor compliance scope.
RP & Stakeholder Liaison: Serve as the central internal contact for the external RP/WDA provider, facilitating document reviews, routing GDP-related approvals, and tracking provider deliverables.
Deviation & Complaint Handling: Manage end-to-end complaint resolution and deviation workflows using Quality Forward; oversee GDP-relevant deviations, CAPAs, and change controls in liaison with manufacturing plants and External Supply Operations (ESO).
Audit & Inspection Readiness: Assist in compiling documentation for regulatory GDP inspections and internal audits, maintaining the inspection readiness repository, and preparing audit responses alongside corporate QA.
Distribution Oversight & Metrics: Track supply chain traceability for cross-border distribution, verify third-party logistics (3PL) compliance with EU GDP guidelines, and track commercial quality Key Performance Indicators (KPIs).

Candidate Profile & Eligibility Criteria

Education: University degree in Pharmacy (B.Pharm/M.Pharm), Chemistry, Biology, or relevant Life Science discipline.
Core Competencies: Practical knowledge of EU GDP guidelines, global pharmaceutical QMS, supply chain compliance, and general GxP frameworks.
Systems & Soft Skills: Proficiency in digital document management systems, deviation-tracking tools, Microsoft Office suite, and fluent English communication.

Position Summary