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QA consultant Antwerp Belgium, Breda Netherlands,  

QBD (company)


Posted on : 04 April 2017

Project Description


QA consultant
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). 



Requirements:
  • 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. 



Offer:
  • 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. 

Locations

Wilrijk BelgiumBreda Netherlands

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