Agent expected skills:
Pharma GMPs main regulations knowledge (at least comprehension and/or ability to work on):
- 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
- Experience in project management in TT projects or similar context
- Management or involvement in an average number of TT projects (not less than 5 )
- Experience in manufacturing of complex pharmaceutical forms such as: aseptic process of drug product, lyophilized products, biological products, biotechnology/ biosimilar products
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
La selezione rispetta il principio delle pari opportunità (l. 903/77)
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CAI
CAI is a 100% employee-owned company established in 1996, providing commissioning, qualification, validation, start-up, project management and consulting services to FDA regulated and other mission critical industries
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