Product Quality Associate

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 follow-up.
• Assist with the further build-out 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.
• Know-how 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 fast-paced biotech organisation with challenging timelines.
• Fluency in the English language with knowledge in the working language.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.

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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