As the Quality Management Systems Specialist, you will be working at the Manufacturing Support Center, a part of the Supply Chain Management department, that provides warehousing and weigh and dispense activities for the Biotech Production. A new warehouse is currently under construction that will hold weigh and dispense booths (Grade D), a high bay area with temperature controlled storage areas as well as other functionalities. The building will be commissioned mid-2017.
Reporting into the MSC Project Manager the Sr Specialist GMP Implementation is responsible for defining, creating and implementing the Quality Management System for transferring the existing warehouse operation into the new SB building.
One of the first actions will be to give follow up on the change control process. Furthermore all existing documentation (SOP’s, Work Instructions, Procedures) will have to be reviewed and brought in line with the new situation. A GAP analysis has to be performed and an improvement/implementation plan needs to be established that meets the overall project timeline (qualification Jun-Oct 2017). Formal training has to be developed and training of the team needs to be executed. You will both be leading this process as well as writing the required documentation. Support is available within the Manufacturing Support Center organization and project team.
Planned Go-live date is December 1st 2017 after which an aftercare period for app. 3-6 months will be required.
• Project change control process
• Adapting of the existing QMS documentation and defining and writing of the required docs
• Interface with cross-functional qualification team
• GAP assessment and closure with respect to the QMS
• Develop and implement training
• Aligns documentation & procedures with Asset Specialist (implementation of new equipment)
• Be the GMP expert for all functional activities within warehouse organization
For the position of Quality Management Systems Specialist we look for candidates with the following profile:
• MSC-level or BSC++ in Technology or Industrial Engineering and Management
• Working experience with (bio) chemicals in an operational API Pharma / Biotech environment preferably with warehousing/dispensing and cleanroom experience
• Proven knowledge of and experienced in implementing GMP and GDP standards
• Must have a high standard for compliance
• Certified Green Belt and 2-3 year experience with Lean Six Sigma (preferably)
• Project Management skills (preferably)
• Experience with SAP (preferably)
More information + how to apply For more information or an extended job description please contact Cindy van Gorp on 040 - 7999 010 or – Klik op de solliciteer-button om te solliciteren –
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