As a Quality Assurance Officer you take GxP requirements into account during preparation, execution and reporting of GxP activities. You are fully aware of key SOPs such as procedures for Events, OOS and good documentation practice. You follow mandatory GxP training and maintain an appropriate training record, you identify and escalate GxP issues.
Your job
- Batch review and preparation QP batch release of intermediates, Drug Substance, Drug Product and Finished Product
- Opening, monitoring and timely closing of minor deviations
- Assessing deviations
- Investigating and handling product complaints
- Review, follow up and close Corrective and Preventive Actions (CAPAs)
- Drafting and executing minor Change Controls
- Delivery of data for monthly Metrics and Management Review and for annual Product Quality Review
- Doing and executing improvement proposals
Your profile
- HBO/ Academic (master’s degree)
- 2 years of experience for HBO or young academic (Msc)
- Strong knowledge of the GMP-guidelines and experience with aseptic manufacturing preferred
- Experience with Trackwise/Mastercontrol/ SAP or similar
- Strong English writing skills, Dutch speaking
- You naturally take a proactive approach, analytical thinker and clear communication.
Our offer
We offer you a fulltime position with the following employment conditions
- A market-rate salary
- A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
- A fulltime employment of 40 hours per week
- Flexible working hours after deliberation
- Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
- Good accessibility by public transport and we provide private parking;
- Sound pension provision.
More info
If you would like to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your resume and motivation via the apply button on this page. We aim to respond to you within a week.