We are looking for a Quality Assurance Supervisor/QP.
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
- 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
- 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