Beschreibung
Validation Lead (IT) vacancy for a globally operating Zug based company in the pharmaceutical sector.Your tasks:
- Ensuring that the Computer System Validation on the project is conducted in a consistently high standard and that objectives are met on time
- Leading the development of documents, processes, and procedures of the Computer Systems Validation program
- Generating, reviewing, and approving Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
- Providing regulatory and retention requirements plus coordinating with Computer System vendors as needed
- Ensuring all project related risks are well managed as well as deliverables are validated and project team complies with the methodology and SOP and uses the correct tools
- Preparing project and life-cycle reports and reviewing/approving all other documents to ensure compliance with SOP
Your experience/knowledge:
- 10+ years of professional experience with Computer System Validation experience in a GxP Pharmaceutical / Diagnostics facility
- 3+ years of experience as a Validation Lead in a project environment, preferred in a matrix organization
- Strong knowledge of Automation Control Systems, Manufacturing and IT Systems plus methodologies including GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
- Hands-on experience in development and review of computer validation documentation
- Language skills: English - fluent in written and spoken, German is beneficial
Your soft skills:
- Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
- Excellent communication skills and the ability to work as a team player in a consulting environment
Location: Zug, Switzerland
Sector: Pharmaceutical
Start:
Duration: 06MM+
Ref.Nr.: BH 19464
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Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are welcome, we will support you all the way.
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