Client: CAI
Location: Bologna / Milano
Job Category: Other
EU work permit required: Yes
Job Reference: 131427590972479897633710
Job Views: 2
Posted: 18.02.2025
Expiry Date: 04.04.2025
Job Description:
Europe Life Sciences – South Europe / Full Time / Hybrid
Agent expected skills:
* Pharma GMPs main regulations knowledge (at least comprehension and/or ability to work on):
1. Technology Transfer: at least 4/5 years of experience in a TT team as Process Technology SME (alias process Manufacturing Science and Technology/Process Engineer) or Process Validation SME
2. Experience in project management in TT projects or similar context
3. Management or involvement in an average number of TT projects (not less than 5)
4. Experience in manufacturing of complex pharmaceutical forms such as: aseptic process of drug product, lyophilized products, biological products, biotechnology/biosimilar products
5. Cleaning Validation experience
Other Desired Experience:
* Developing Validation / Verification Master Plans
* Performing formal risk assessments / FMEA
* Change Control - CAPA process
* Identifying Critical Attributes and Critical Process Parameters
* Commissioning and Qualification
* Developing User Requirements
* Schedule development and execution
* Establishing metrics and leading team to achieve performance goals
* Facilitating meetings
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