Product Quality Associate

il y a 1 mois


Brussels, 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 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.

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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