What are your responsibilities?
- Responsible as technical reviewer/approver for lab equipment qualification, maintenance and retirement documentation, including calibration and testing protocols of external parties guaranteeing compliance quality policies.
- Provides technical expertise in investment projects for laboratory equipment, including selection of vendors and their products, and actively participates in the purchasing decision and process.
- Acts as SME and participates in global projects for Data Integrity activities related to computerized and non-computerized lab equipment.
- Maintain the QCB qualification planning.
- Responsible for providing technical expertise and performing review tasks related to MMD-GCM changes and ECM changes concerning lab equipment.
- Responsible for establishing the annual maintenance program in collaboration with internal and external parties, providing the technical information for contractual terms as needed.
- Participates in site and global quality improvement projects and acts as a point of contact and SME for lab equipment.
- Responsible for initiating changes related to lab equipment.
- Supports lab investigations process as needed.
- Acts as Person in Charge responsible for archive of equipment related documentation.
- Technical approval of purchase and qualification documentation of laboratory equipment in line with current quality directives.
- Acts as quality expert for laboratory instrument maintenance and automation.
- Responsible for the archive of approved documentation
- Assures that documentation is drafted and reviewed/approved according to guidelines.
Who are we looking for?
- HBO or Msc degree related to the Life Sciences field
- Knowledge and experience with quality and compliance guidelines, cGMPs
- Knowledge of industry guidance and respective regulations of Equipment Qualification and Maintenance, Validation, Quality Control, Quality (Management) Systems, Documentation, Change Controls
- Technical knowledge in testing techniques and lab equipment
- Technical Writing, Failure Mode & Effect Analysis (FMEA), and Lean Six Sigma.
- Effective project management planning skills and ability to communicate on prioritization and bring others on the same page
- Computer literacy knowledge
- Ability to work under minimum supervision.
- Strong focus on clients and end-user
- Hands on mentality
- Good communication skills and being pro-active and flexible
- Team work oriented
- Flawless Integrity Mindset (Data Integrity)
- Excellent interpersonal and communication skills, oral and written (Dutch and English)
- At least 5 years of relevant experience preferably in pharmaceutical Quality Control and cGMP. Furthermore, a sound knowledge of equipment design and use.
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.