QA Specialist Review/release

vor 2 Wochen

Leverkusen, Deutschland Proclinical Vollzeit

Proclinical are recruiting a QA Specialist Review/Release for a pharmaceutical corporation. This role is on a permanent basis and is located in Germany. The client is focused on changing the findings, developments, and productions of biologics through a thorough open-access platform.

**Responsibilities**:

- Assist with regulatory proposal documentation and be prompt for inspections.
- Offer aid for planning regulatory proposals and actions to be prompt for inspection.
- To ensure data integrity and offer direction from a QA perspective, which may involve deviation, CAPA, change control, qualification, etc., you will manage audit quality documents of functional divisions.
- Aid in the release of raw material, IPC, equipment, rooms, utility, facility, etc.
- You will discuss with client QA when required assisting with the release of bulk drug substance.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to a degree level in a technical or pharmaceutical field such as biochemistry, biology, chemistry, pharmacy, etc.
- Familiarity with working in a biotechnology and/or pharmaceutical organisation in a quality role.
- Capable of comprehending technical documentation.
- Expertise on GxP needs and guidelines.
- Acquaintance with assisting with internal audits would be preferable.
- Works well in a team environment.
- Communication skills both verbally and in writing.
- Fluency in the English language with knowledge in German would be ideal.

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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