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Drug product msat process specialist

Basel
Coopers Group GmbH
EUR 30’000 - EUR 80’000 pro Jahr
Inserat online seit: 27 April
Beschreibung

1. Support Product Technical Leads and Product Stewards to ensure process industrialization (e.g. facility t and manufacturability, PPQ support as needed, etc…), coordinate and execute process gap assessments, integrating identified risks into the risk log and developing mitigation strategies.
2. Drive systematic process and continuous technical product health and supply improvements based on insights, including second supply and change source strategies
3. Execute validated state support activities, such as WCB shipment, sample coordination for additional studies, and non-routine sampling planning, and respond to evolving conditions to ensure compliance (e.g. VICs, RCAs, etc.)
4. Provide technical expertise to technical runs and engineering runs, internally and externally
5. Provide hands‑on second‑level support (commercial product support) in the case of investigations, CAPAs and troubleshoot in close partnership with the internal and external manufacturing network
6. Lead non‑product specific RCAs and investigations on behalf of the internal manufacturing network
7. Leverage the pilot plant team to enable real‑life and scaled experimentation to support process related projects (including validation studies) as well as process

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