What are your responsibilities?
- Represent and manage the delivery of site and NPI (New Product Introduction) projects. The delivery of these projects will require GMP utility, facility and supporting system changes.
- They must investigate and deploy innovative solutions to improve the efficiency of our current installations.
- Ensure procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements.
- They will work directly with SMEs, vendors and customers to ensure regulatory (e.g. validation), business, functional and application specific requirements are met.
- Generation of proposals for the 2019 program.
- Execute projects to Amgen Project Execution Plan (PEP) and meet all GMP requirements.
- Ensure the highest levels of project safety.
- Perform continual project risk analysis.
- Identify project critical paths and prioritize accordingly.
- Discover and understand end-user/process requirements; translate these into user requirements specifications.
- Manage the compilation of all project documentation.
- Manage design inputs to ensure robust, testable requirements are established and accurately reflect user and safety needs.
- Manage day to day project activities including permitting/method statement review etc.
- Develop and document strong rational for testing strategy, acceptance criteria, and results.
- Generate, review, and/or approve protocols, reports ensuring robust documentation for regulatory adherence.
- Monitor installation quality and record inspections – Comply to Amgen and Dutch standards.
- Set up and manage communication channels – Weekly report out/Project Team Meetings.
- Follows a strict handover process to allow for future system maintenance.
- Managing Key business stakeholders expectations/interactions (Planning, Manufacturing, Warehouse & Distribution, Customer Service and Quality).
- Work with impacted functions to ensure alignment and operational readiness of new installations.
- Manage resource & skills allocation and management of day-to-day activities.
Who are we looking for?
- MSc/HBO in a Life Sciences related field such as Life Science and technology, Biomedical Engineering & Biotechnology
- Experience in a pharmaceutical/GMP environment
- Experience in a labeling and packaging environment
- Project management qualification or 5+ years Project Management experience
- Experience with MS Project
- Cost/budget control Experience
- Prior Experiences with Change management
- Excellent communication skills
What does QbD offer you?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
Interested? Apply now by sending us your CV and motivation.