This job is currently Archived,
Posted on : 04 April 2017
You are Subject Matter Expert related to qualification of the systems and processes and from this expertise you are:
- QA support for production, engineering and qualification teams.
- QA subject matter expert for event and deviation handling and provide advice from your quality expertise.
- QA support for strategic projects for the site.
- QA support in regulatory inspections.
- Lead in quality optimization projects.
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, policies and standards.
- Giving input in changes and investment projects leading to advancement in process technology.
- Actively look for the best qualification solutions.
- Review and approval of change controls related to production equipment, production processes and utilities.
- Active participation, review and approval of Periodic System Quality Reviews (PSQR).
- Master degree in technical / chemical / pharmaceutical area or equivalent through 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.
- Previous experience in a QA function is preferred.
- Previous experience in qualification is preferred.
- Demonstrated ability to manage QA aspects within complex projects, priorities and multiple tasks.
- Fluent in Dutch and English.
- a young, dynamic company with a let s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
- personal and professional development through guidance, education and knowledge sharing
- a competence development model focused on your personal ambitions
- an attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.
Wilrijk BelgiumBreda Netherlands
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