Talent Acquisition Consultant at Coopers Group AG - Life Science
Contract duration: 12 months, with potential extension
Location: Basel
Home office: 1 day per week
Languages: German and English (mandatory)
Job Description
As an end-to-end (E2E) process expert, you will be responsible for ensuring the E2E process in aseptic production at the Drug Product Clinical Supply Center Basel. You will collaborate closely with process and technical experts from manufacturing companies to carry out your tasks.
Responsibilities
1. Support in-house manufacturing orders at batch level and support manufacturing plants (compounding, aseptic filling, visual inspection) from creation to approval of manufacturing instructions and batch records.
2. Approve recipe-related parts lists and MES manufacturing instructions.
3. Troubleshoot batches and manage deviations in cooperation with manufacturing plants.
4. Serve as change owner for process modifications with process experts and support groups.
5. Draft process SOPs and high-level SOPs in collaboration with subject matter experts.
6. Act as Subject Matter Expert (SME) in handling complaints.
7. Coordinate batch record review and release with quality assurance, considering customer timelines.
8. Maintain cleanroom status and support routine microbiological monitoring in collaboration with QC.
Requirements
1. Degree in life sciences or engineering (e.g., pharmacy, biotech, biology).
2. Fluent in German and English.
3. Minimum 5 years of experience in pharmaceutical GMP manufacturing, quality assurance, quality control, or process engineering, particularly in sterile dosage forms.
4. Strong knowledge of aseptic manufacturing processes and GMP documentation.
5. Experience in writing deviation reports and GMP documents.
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