Process Optimization Specialist
5 days ago
**Job Summary:**
We are seeking a Process Optimization Specialist to join our client's team on a permanent basis.
The ideal candidate will have extensive experience in tech transfer and commercial manufacturing.
This role offers flexibility to work remotely and involves some travel.
Main Responsibilities:
- Lead the review of all GxP manufacturing and packaging documentation from contract manufacturing sites
- Support dossier compilation and review for all new drug products
- Liaise with other internal departments to ensure timely implementation of necessary manufacturing documentation
- Perform CPV and identify trends
- Implement changes identified from CPV, cGMP standards requirements, process improvements or corrective actions
- Prepare, review and approve SOPs
- Conduct and support manufacturing process investigations to drive operational excellence and continuous improvement
- Evaluate new suppliers from a technical manufacturing perspective
Requirements: B.Sc. in a science related discipline (Chemistry, Engineering, Biotechnology, Pharmacy etc.) and 10 years relevant experience in a cGMP pharmaceutical manufacturing environment.
Key Requirements:
- Experience in multiple manufacturing process areas such as technology/product transfer, process scale up, process optimisation, process validation and routine manufacture
- Extensive manufacturing experience with multiple dosage forms including but not limited to sterile, oral liquid and solid oral dosage products
- On floor/in plant experience required
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