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Senior QA Specialist Antwerp Belgium, Breda Netherlands,  

QBD (company)


Posted on : 04 April 2017

Project Description


Senior QA Specialist
  • Perform QA support and oversight for equipment, automation and IS validation. 
  • This function does NOT develop the technical solutions. 
  • The QA validation specialist will work under supervision of qualified on site staff. Level of in dependency will vary based on familiarity with the subject (e.g. equipment, automation, etc). 
  • Expectation is that staff can perform selected QA validation activities within one month from starting date. 
  • Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met. 
  • Keeps quality oversight on validation strategy and deliverables for specific projects. 
  • Maintain a close contact and familiarity with local Quality systems. 
  • Provide guidance and direction to Quality, Production, Warehouse/Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.  




Requirements:
  • Master Degree in Engineering, Pharmaceutical sciences, Process Technology, or equivalent. 
  • 10 years of professional experience in GMP environment. 
  • 5 years relevant experience in Equipment and Automation Validation, preferably related to secondary packaging. 
  • Additional experience with Non Conformance, CAPA s and Change Control 
  • Expanding knowledge of GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11). 
  • Good attention to detail and excellent writing skills in English language. 
  • Effective communication skills at multiple levels and areas (inside and outside of Quality). 
  • Good decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc. 
  • Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. 
  • Works under minimal direction. 
  • Work is guided by operational and project objectives. 
  • Manages multiple assignments and processes. 
  • Independently determines approach to project. 




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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