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QA Operations officer

Prothya Biosolutions makes life-saving plasma medicines and is proud of it! Every day, Prothya colleagues are delighted to go the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible, fast-growing company with an interesting history? Then the position of QA Officer at our Quality Assurance department might be something for you! At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn! Are you moving along? Then apply now!

QA Officer - AMSTERDAM

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.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.

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