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Vacature Technical Qa Specialist

Vacature Breda

  • 10 Select
  • Universitair of hoger
  • Senior niveau
  • Vast contract
  • 40 uur p/w
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Beschrijving vacature As Technical QA Specialist you will report to the Senior Manager QA. The Breda technical QA group keeps oversight on introduction and modification of equipment, information systems and packaging configurations for commercial secondary packaging operations. By controlling the critical aspect of our operations and systems throughout the life cycle, we safeguard the high quality of our medicines. Additionally, we provide quality engineering support for quality investigations and testing strategies.The Technical QA Specialist will be the liaison between quality and engineering to ensure new equipment is introduced within manufacturing conforming quality guidelines. You will work closely together in different project teams with the following departments: Process Development (PD), Maintenance and Engineering (M&E), Production, Information Systems (IS) located both in Breda and internationally.What are your key-responsibilities?
  • Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment and information systems in cooperation with the other departments;
  • Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements by reviewing and approving validation documentation;
  • Provide support to Plant QA regarding equipment or information system related production issues. You provide quality engineering support to establish appropriate sampling plans and acceptance criteria;
  • Project team member to develop efficient quality processes and translate them in standard operating procedures;
  • Perform final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.

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Salarisinformatie Salaris in overleg
Contactpersoon 10 Select
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