Quality Assurance Specialist

Overview

Quality Assurance Specialist responsible for supporting pharmaceutical GDP/GxP compliance, WDA license activities, documentation, and quality processes including complaints, deviations, CAPAs, and audits.

What you'll do

• Support maintenance of the Dutch WDA license with the external RP service provider.
• Ensure WDA compliance documentation is complete, current, and accessible.
• Coordinate internal inputs and timely information exchange for initial and ongoing WDA obligations.
• Coordinate review and routing of GDP-relevant documents requiring RP approval.
• Manage end-to-end complaints, deviations, and CAPA processes with accurate recording and communication to sites.
• Support preparation for GDP inspections and responses to audit questions with RP and corporate QA.
• Track quality actions, closure, and change controls affecting the WDA scope.

What you'll need

• University degree in Pharmacy, Chemistry, Biology, or relevant Life Science.
• Knowledge of pharmaceutical GxP regulations and Quality system.
• Strong understanding of GDP principles (EU GDP Guidelines).
• Experience in pharmaceutical quality systems or supply chain compliance.
• Experience coordinating external service providers and internal stakeholders.
• Strong documentation, organization, and communication skills.
• Advanced knowledge of English and good Microsoft applications/computer skills.

Details

• Location: Ankleshwar, India.