Job Responsibilities
1. Perform standard activities or routine tasks, e.g., batch records reviewer, and support project work. Ensure the timely release of GMP relevant documents and batches, adhering to cGMP standards in TRD.
2. Receive incoming documents (e.g., executed batch records, work orders, vendor labels, packaging instructions) and document them in the respective tools. Prepare documentation required for batch record review, such as Analysis Reports, Specifications for clinical development, and country label approval.
3. Support the timely release of GMP batches of labels, primary packed materials, and Investigational Medical Products.
4. Review and approve GMP relevant documents, including work orders, packaging master documents, clinical study labels, and batch record reviews for both internal and contractor-produced packed materials. Manage notifications of extension due to revised expiry dates and maintain GMP relevant documents in your area of responsibility (e.g., Certificates of Compliance, Batch Record Review Checklists).
5. Scan, file, and archive QA-owned documents such as Certificates of Compliance and Batch Record Review Checklists.
6. Write and review procedures and forms related to the QA Batch Record Review Process.
7. Contribute to performance reports ensuring 'Right First Time' for the release of IMPs.
8. Collaborate with QA & GCS Line Units on process improvements, quality and compliance issues, and the use of GMP relevant IT tools and processes.
9. Support the use, improvement, evaluation, and implementation of GMP relevant IT tools and processes.
Qualifications and Experience
* Relevant working/residency permit or Swiss/EU citizenship required.
* Technician or Bachelor’s degree with at least 3 years of experience.
* Fluent in German and English, both oral and written.
* Strong communication skills to address GMP and logistics-related questions with line unit experts.
* Scientific, technical, and regulatory knowledge in a specific area, with basic knowledge of drug development.
* Detailed knowledge of cGMP, and working knowledge of safety and environmental regulations and guidelines.
* Good organizational skills.
Location: Basel and NW Switzerland, CH
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