You are QA Support related to qualification of our production systems and equipments and from this expertise you are:
- QA support for production, engineering and qualification teams.
- QA support for change control and event /deviation handling and provide advice from your quality expertise.
- QA qualification support during changes and strategic projects for the site, including QA qualification support for the project “continuous manufacturing” within the pilot plan.
Your main responsibilities consist out of:
- Assuring that the qualification status is maintained during assessment and execution of changes and projects.
- Review and approval of qualification documents such as master documents, validation plans, protocols, reports, rationales, SOP’s in order to maintain compliance to regulations, guidelines, J&J policies and standards.
- Guarding the cGMP aspects in the different qualification projects
- Review and approval of change controls related to production equipment
- Review and approval of qualification discrepancies and related corrective actions
- Review and approval of Periodic System Quality Reviews (PSQR) and Validation Master Plans (VMPs)
- Master degree in technical / chemical / pharmaceutical area or equivalent through experience.
- Qualifications Education & experience
- Working experience in regulatory controlled environment: 21 CFR Parts 210, 211; EU Directive 2003/94/EC and annexes; Eudralex Volume 4 GMP guidelines and annexes.
- Working experience in regulations regarding electronic data: 21 CFR part 11, GAMP’s. P
- Previous experience in a QA function is preferred.
- Previous experience in production equipment qualification is required.
- Demonstrated ability to manage QA aspects within complex projects, priorities and multiple tasks.
- Excellent verbal and written communication skills
- Collaboration and teaming skills
- Strong quality mindset
- Fluent in Dutch and English
- Persuasive and credible to act as subject matter expert during internal and external regulatory inspections
- Influencing and negotiation skills
You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.
Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.
For one of our pharma clients in Beerse we are looking for a QUALIFICATION ENGINEER (M/V).