QA Sterility

il y a 7 jours

Antwerpen, Flandre, Belgique Jefferson Wells Belgium Temps plein

Contracting – Antwerp

Responsibilities :

The QA Sterility performs/supports the performance of the following activities related to the assigned product(s) as per the companies procedures:

-Microbial control of process, cleanroom and clean utility

  • Ensures microbial control of process, cleanroom and clean utility systems by setting up monitoring plans, setting limits, perform trend evaluations, define improvement actions.
  • Delivering Performance qualification documents for clean utility and cleanroom systems.
  • Perform trend evaluation and reporting of microbial data for process, cleanroom and clean utilities.

-Deviations and Change Controls

  • Perform investigations as coordinator and/or investigation leader for deviations related to process, clean utility or cleanrooms.
  • (Pre-)Asses the microbial impact of proposed changes
  • Provide microbial information as part of deviation to further assess the impact on product.
  • Elaborate the overall Contamination Control strategy within the site.

-Transversal activities

  • Actively participate in awareness and training sessions regarding Contamination Control for the Geel site.
  • Acts as the contact person with regards to Contamination Control expertise.
  • Participate and supports in site inspections and audits

-Support site improvement projects as Contamination Control (Launch platform for new clinical products, EFA ramp-up, Dupilumab acceleration, ...)

Your profile ?

  • Master's degree or equivalent in Pharmaceutical/ Biotech/ Life sciences
  • Preferably 1- 3 years' experience in the pharmaceutical industry of manufacturing and/or quality operations.
  • Relevant experience in Contamination Control/Sterility Assurance department

Our offer:

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You're interested in this job? We kindly invite you to apply or send me your CV, adela.amzert@jeffersonwells.be

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