Commissioning & Qualification lead

WHAT ARE YOUR RESPONSIBILITIES?

  • You will report to the project’s Execution Systems Lead
  • You will  coordinate all project validation deliverables / test stages whereby leading a team of C&Q Leads (C&Q Document Lead, C&Q Execution Lead):
    • Driving / leading the validation plan E2E with key focus on safety, quality and schedule attainment:
      • HAT, SIT, IQ, SW FAT, Commissioning, Qualification (IQ, OQ, PQ)
      • Impact Assessments, Risk Assessments, Design Review, Requirements Traceability Matrix
      • Deviation & Change Management
      • Configuration Management
      • Equivalency / Leveraging Management
    • Pro-actively tracking and steering all prerequisites leading into each test stages, and this for multiple parallel test streams
    • Drive planning, scheduling and tracking of schedule
    • Resolving problems in a compliant manner before they stop the project
  • You will engage with Execution Systems, Operations, Technical Operations, Software, Equipment, Validation and QA  team members 

WHO ARE WE LOOKING FOR?

  • You have a master’s degree in life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer, …)
  • You have experience in the life science industry and in GMP and GDP
  • You have experience in  Project Delivery, Validation, C&Q experience
  • You have relevant technical expertise in: DCS systems, preferable Emerson DeltaV ; Batch Control ; ISA S88.
  • (equipment/process/E&I/DCS)
  • You have excellent interpersonal and communication skills
  • You have strong problem-solving skills and can work under pressure

WHAT DOES QBD OFFER YOU?

  • 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.

Interested? Apply now by sending us your CV and motivation.