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Quality Assurance Officer Maastricht Netherlands,  

PharmaCell (company)


Posted on : 10 April 2017

Project Description


The Position
  • In this position, you are responsible for planning and execution of daily quality documentation while ensuring compliance with all existing GMP and safety standards in the area of responsibility.
  • You will work in a team of young, driven professionals in a GMP environment on projects related to cell therapy and regenerative medicine. 
  • The Quality Assurance Associate works with autologous and allogeneic cell products in accordance to GMP guidelines.



Tasks and results:
  • Generate, revise, review control, archive and process of controlled GMP documentation. 
  • SOP s, manufacturing and quality Batch Records, validation of protocols and reports, non-conformities, change requests). 
  • Monitor compliance with all applicable GMP and safety standards. 
  • Administrating and reporting progress on the Quality Key Performance Indicators (QKPI) in a QRB setting, such as Non-Conformances, Change control and CAPAs. 
  • Acting as assigned QA core team member in company  projects. 



Qualifications
  • BSc degree in Life Sciences- biochemistry, biology or biotechnology with relevant experience in a GMP related industry is required. 
  • Good knowledge of cGMP regulations, preferably in Advanced Therapeutic medicinal Products (ATmPs) and the current Industry Standards. 
  • Good communication skills in English. 
  • Demonstrated proficiency in MS Office. 
  • Accuracy, tidiness, self-organized, flexible, attention to detail, team player. 

Locations

6229 EV Maastricht Netherlands

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