Our client is active in the Netherlands as well in Belgium. Main focus is in the branches Food, Pharma, Oil and Gas.
The core business is to support there clients trought consulting and engineering, deliver of turn key process/automation/gmp solutions and deliver of maintanance and support.
- Generates qualification protocols and final reports, for utilities, facilities, equipment (including computerized systems), instruments qualification, and cleaning and process validation. (For the project experience with impact assessments, commissioning, IOQ, Cleaning validation, Purified water systems, Autoclaves, Lyophilizers, Centrifuges, HVAC, clean steam generators, air compressors; Instrumentation and Control.is an advantage)
- Develops and includes as required, testing for the computerized control system for equipment and systems during their qualification exercise.
- Supports and maintains the Validation Master plan and the Laboratory equipment and instrument qualification and validation including test methods and test methods transfers.
- Aligns qualification and validation activities to meet Plant goals.
- Identifies and elevates any situation that could potentially impact the quality of the product, production interruption and the safety of personell
- Develops and revises SOPs, change controls and can also act depending on the roles, as approver of protocols and final reports.
- Prepares the qualification and validation schedule based on the activities assigned by the Quality System Manager and aligns these activities with other functional areas.
- Ensures that the qualification and validation exercises comply with applicable regulations, manufacturer specifications and with internal guidelines and procedures.
- Ensures compliance with the Change Control Program for qualified utilities, facilities and process equipment, and process / cleaning validation.
- Ensures customer service satisfaction and maintains a quality mindset promoting compliance throughout his/her work execution.
- Generates validation department key performance indicators, CAPA status reports, projects updates, provide training to contractors.
- Assures training compliance at all time and monitors training compliance of the validation team.
- Is part of the part of the plant CAPA team and issues protocol deviation reports and provides support to the plant when needed on general and process investigations, CAPA actions, and Internal Audit program.
- Responds to requests made by CAPA Manager and Quality Director during routine and during regulatory and internal audits.
- A minimum of five (5) years of experience in a similar position in Pharmaceutical or Biotechnological Related Industry.
- A Bachelor Degree in: Microbiological, Biochemical, Quality Engineering or Engineering Sciences or Chemistry.
- Capable of work under pressure and in a dynamic environment.
- This position requires excellent reading, writing and speaking English. The ability to speak Dutch is a big plus
- You have to be able to utilize Microsoft Office Professional Software package including MS Word, MS Excel, MS PowerPoint, and MS Project Management.
- Availability: The applicant shall be able to work overtime and weekends when needed