Quality Assurance Supervisor/QP (ID 201)

Introduction

We are looking for a Quality Assurance Supervisor/QP.

Organization

You will be actively involved in cluster projects and QA improvement initiatives. Ensure appropriate contacts with the country Regulatory Affairs (RA), Vigilance, Warehouse & Distribution (W&D), QA Manufacturing and Businesses are maintained.

You ensure that processes and procedures related to mentioned activities are compliant to legislation, to the Corporate Quality Manual and to the ISO 9001/13485 requirements

Function

  • Being the Qualified Person of the Distribution Centre Europe
  • Being the contact with authorities for all quality related aspects.
  • CAPA and complaints management
  • Launch non-conformances when it is required; act as initiator or owner or QA approver
  • Assisting in CAPA’s launched for the entity
  • Being the QA reviewer / approver for SCARs Audits and Inspections:
  • Participating to the annual Internal Audit program and to the Supplier Audit program with SQA for suppliers, as qualified lead auditor.
  • Representing CQA during external and internal
  • Actively participate in local/regional projects, business initiatives
  • Support change control & NCR related to relabeling, GMP or Infrastructure works
  • Being the QA contact person for the Raw Material warehouse and 3rd party suppliers
  • (warehousing, relabeling)
  • Being the contact person for QA plants and for re-inspections
  • Being the contact person with Regulatory and Product Design Owners
  • Providing support for validation
  • Being a JDE and WMS expert user
  • Being a TW8 expert user, including training of users, when required
  • Being QA SME for relabeling, including validation
  • Leading GMP related projects


Requirements

  • Master’s degree in Pharmaceutical Sciences
  • Advanced Master’s in industrial pharmacy
  • Certified QP from Belgian FAMHP
  • +2 years of experience in Pharmaceutical Sciences, Good Distribution Practices, Good Manufacturing Practices
  • Excellent knowledge of applicable Legislation, Eudralex, cGMP, cGDP and Quality Systems
  • Fluent in English and French
  • Good computer skills (Outlook, Windows, ERP, Word, Excel, etc)
  • Can work autonomous on identified and specific tasks (e.g. SOP implementation, local project)
  • Strong communication skills: interact efficiently with all levels of local and international organization
  • Team spirit minded


Luc Decat
Type of contract Permanent
Sector Medische apparatuur
Country Belgium
Job family Quality