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description de la société
For a major player in the global pharmaceutical industry, we are looking for a QA Associate Qualification.
description de la fonction
Randstad’s mission is to shape the world of work by being a world leader in matching supply and demand in the labor market and in HR services. Randstad Professionals is part of the Randstad Group and creates opportunities for highly qualified and skilled professionals to work on successive projects on customers’ site.
You are QA Support related to qualification of our systems and processes 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.
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. • Guarding the cGMP aspects in the different qualification projects • Review and approval of change controls related to lab 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)
If this description fits your profile, send your resume to: email@example.com
Education & experience:
• Master degree in technical / chemical / pharmaceutical area or equivalent through experience. • Minimum 3 years of 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. • Excellent verbal and written communication skills • Collaboration and teaming skills • Focused on solutions • 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 • Mindset for innovation and optimization.
You are flexible and you will receive a lot in return. You will get an attractive salary package with extra benefits: - group insurance, - hospitalization, - meal vouchers, - representation costs - training, ...