COMMISSIONING AND QUALIFICATION LEAD

GeelIFarmaceutische industrie

Functieomschrijving

For one of our pharmaceutical clients in Geel we are looking for a COMMISSIONING AND QUALIFICATION LEAD. 

Context:
The site is running on outdated process control systems (RS3 and S5 PLC systems). The migration to a new standard process control system is necessary to keep the plant operational to safeguard the supply of the strategic growth products and to maintain the launch capabilities.

As a COMMISSIONING AND QUALIFICATION LEAD you are responsible for:

  • Reporting to the overall C&Q Lead
  • Overall coordination of all project C&Q document deliverables:
    • Driving / leading the validation plan E2E with key focus on the creation of related documentation:
      • HAT, SIT, IQ, SW FAT, Commissioning, Qualification (IQ, OQ, PQ)
      • Impact assessments, risk assessments, design review, requirements traceablitiy matrix
      • deviation and change management plan
      • configuration management plan
      • equivalence / leveraging management plan
    • Proactively tracking and steering all prerequisites leading into each C&Q document creation
    • Drive planning, scheduling and tracking of schedule
    • resolve problems in a compliant manner before they stop the project
  • Overall coordination of the project observation / deviation / change control process, closely tied in with the configuration management of the Delta V SW
  • Engaging with Operations, Technical Operations, Software, Equipment, Validation and QA SME’s / project team members in support of completing the C&Q protocols / test forms and related deviation
Profiel

As a COMMISSIONING AND QUALIFICATION LEAD you possess the following skills and competences:

  • You have a degree in Engineering or relevant through experience
  • Pharma experience is a big plus.
  • You have good interpersonal and communication skills
  • You are a true teamplayer
  • You are able to work well under pressure
  • You have relevant technical expertise (DCS systems preferable Emerson DeltaV – Batch ISA S88)
  • Knowledge about GAMP 5 is preferred.
  • You have a GDP/GMP experience and mindset
  • You are fluent in Dutch & English
  • You have C&Q experience (equipment/process/E&I/DCS)
Organisatie- en afdelingomschrijving

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, the Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

Aanbod

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Heb je nog vragen?
Bénédicte Joret Technical Projectsourcing Select Projects +32 3 203 50 88
COMMISSIONING AND QUALIFICATION LEAD Vacature informatie
68035
Techniek - projecten
Project sourcing
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