Product Quality Associate

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique ProClinical Temps plein

Salary:

Highly Competitive

Job type:

PermanentDiscipline:

Good Manufacturing Practice (GMP)
Location:

Belgium- Brussels, Belgium

  • Posting date: 05 Feb 2024

Reference:
57885

Proclinical are recruiting for a Product Quality Associate to join a biotech organisation. This role is on a permanent basis and is located in Belgium.

Responsibilities:

  • Supervise the performance of the manufacturing procedures through metrics.
  • Partake in both internal and external audit planning and followup.
  • Assist with the further buildout of quality procedures and systems.
  • Help the QA team with additional ad hoc project assistance.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Demonstrable experience within a quality assurance role, handling biopharmaceuticals with experience within biological manufacturing operations.
  • Familiarity with batch record evaluation would be beneficial.
  • Acquaintance working in an outsourced model, working alongside a CMO would be advantageous.
  • Prior involvement with audits as well as with preparing regulatory inspections such as FDA, EMA, PMDA, etc., would be beneficial for the role.
  • Knowhow of both FDA and EU guidelines and ICH regulations.
  • Technical, analytical and investigation abilities.
  • Precise in implementation and reporting with a quality mindset.
  • Works well with others.
  • Capable of working within a dynamic setting of a fastpaced biotech organisation with challenging timelines.
  • Fluency in the English language with knowledge in the working language.


Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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