QA Associate QMS

Are you passionate about quality and precision? Join this team as a QA Associate and help ensure top-tier standards every day.

Proclinical is seeking a QA Associate QMS to support the timely release of GMP-relevant documents and batches, ensuring compliance with cGMP standards. This role involves routine tasks such as batch record reviews and supportive project work within the TRD GCS environment.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Receive and document incoming materials such as batch records and packaging instructions.
• Prepare necessary documentation for batch record reviews.
• Support the release of GMP batches, including labels and primary packed materials.
• Review and approve GMP-related documents, including work orders and clinical study labels.
• Conduct batch record reviews for both internal and contractor-packed materials.
• Compile notifications for revised expiry dates and manage GMP documents in your area.
• Scan, file, and archive QA-owned documents.
• Write and review procedures related to the QA Batch Record Review Process.
• Contribute to performance reports for the release of Investigational Medical Products (IMPs).
• Collaborate with QA & GCS Line Unit on process improvements and compliance issues.
• Support the use and improvement of GMP-relevant IT tools and processes.

Key Skills and Requirements:

• Technician or Bachelor's degree.
• Fluent in German; proficient in English (oral and written).
• Strong communication skills for addressing GMP and logistics questions.
• Scientific, technical, and regulatory knowledge in a specific area.
• Basic understanding of drug development.
• Detailed knowledge of cGMP and safety/environmental regulations.
• Good organizational skills.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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