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QA Data Specialist

Omgeving Amsterdam
As QA Data Specialist you are responsible for the quality management of the products lifecycle management with a focus on working on Alzheimer disease.  

Locatie

Omgeving Amsterdam

Functie omschrijving

As an enthusiastic Quality Assurance Data Specialist your role centers around quality management of the products lifecycle management (i.e. Change Controls for Artwork, Safety, Specifications, Bill of Materials etc.) in relation with contract manufacturing. The products in scope are Biologics and Pharmaceutical and can cover various product stages (i.e. starting material, API, DP and FG).

Responsibilities

  • Primary focus: ensure from a Quality representative point of view the timely and correct progression of change control for selected products at mainly the Finished Good stage i.e. Labeled and Packed
  • Continuous Improvement - Support review of release processes for simplification
  • Execute on decisions made according to written procedures and standard practices
  • Participate to /Set up meetings for products and area of competence
  • Communicate appropriately any identified issue that could impact the manufacture of the assigned/selected products
  • Develop on a weekly basis a worklist of urgent Change Orders to prioritize the efforts of the Commercial Packaging team

Profiel kandidaat

Qualifications

  • Minimum Bachelor’s degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.
  • 1-3 yrs related experience with data administration
  • Experience working with large data sets is preferred
  • Experience in a GMP environment is a plus
  • Proficiency in Microsoft office applications

Personal skills

  • Demonstrate attention-to-detail, good judgment, problem solving, and ability to make decisions quickl
  • Ability to work independently and in a team environment
  • Verbal communication skills in English are essential in this collaborative work environment
  • Team player
  • Service minded and flexible

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