Contract type - Contract
Start Date - As soon as possible
Location - Basel
Workload - 100%
Duration - 18 months (extension possible)
Your mission:
- Receives incoming documents (e.g. executed batch records, work orders, vendor labels, packaging instructions etc.). Performs documentation in respective tools. Prepares documentation needed for the batch record review (e.g. Analysis Reports, Specifications for clinical development, country label approval etc.).
- Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products.
- Review and approve GMP relevant documents, e.g. work orders, packaging master documents, clinical study labels,... Batch record review for both packed material from internal or contractors. Compiles, Notifications of Extension to be issued due to revised expiry dates. GMP relevant documents in own area of responsibility (e.g. CoC's, BRR Checklists).
- Scan, file and archive documents owned by QA (e.g. Certificate of Compliance, Batch Record Review Checklists).
- Write and review procedures and forms related to the QA Batch record Review Process.
- Contributes to Right First Time performance reports for release of IMPs.
- Supports and collaborates with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes.
- Support the use, improvement, evaluation and implementation of GMP relevant IT tools and processes.
Your background:
- Technician with 5+ years' experience or Bachelor with 3+ years' experience
- Fluent in German, with good speaking and writing English
- Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
- Scientific, technical and regulatory knowledge in a specific area. Basic knowledge of drug development.
- Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
- Good organizational skills.
What's on offer
- An 18 month contract.
- Opportunity to develop your career at an internationally known pharmaceutical company.
- A competitive salary.
If this sounds like you, don't hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
Website
https://www.swisslinx.com/job/16211en
