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16251en
- Contract
- English, French
- Mid-Senior level
- Digital & Technology
- Neuchâtel
- Healthcare & Life Sciences
Skills
Computerized System Validation, CSV, Life Cycle Management, cGMP, Data Integrity, Laboratory, Validation, Qualification, French, English
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Contract – 12 months
Ideal start date – 14.10.2024
100 % pensum
Neuchatel
Your responsibilities:
• Being accountable for the life cycle management activities of systems in the QC labs
• Analysing instrument qualification and the Computerised System Validation
• Supporting the Data Integrity deployment (cGMP, standards policies, EHS requirements)
• Authors of specification documents and reviews protocol and reports as per established company guidelines and SOPs
• Executing and documents Equipment & Software validation.
• Overseeing validation and qualification activities executed by analysts + training and support.
• Identifying and communicating risks in area of responsibility and across the site
Languages (compulsory for this roles):
• French C1
• English C1
Your profile:
• Master’s in engineering, Computer Science, or related technical field
• 5 years+ in validation experience in the biotechnology or pharmaceutical industry
• Proven experience with validation life cycle requirements for cGMPs laboratory systems
• Knowledge of DI requirements and standard regulations for cGMPs operations
Feel free to apply if the position suits you ! Kind regards, Mirella
Ideal start date – 14.10.2024
100 % pensum
Neuchatel
Your responsibilities:
• Being accountable for the life cycle management activities of systems in the QC labs
• Analysing instrument qualification and the Computerised System Validation
• Supporting the Data Integrity deployment (cGMP, standards policies, EHS requirements)
• Authors of specification documents and reviews protocol and reports as per established company guidelines and SOPs
• Executing and documents Equipment & Software validation.
• Overseeing validation and qualification activities executed by analysts + training and support.
• Identifying and communicating risks in area of responsibility and across the site
Languages (compulsory for this roles):
• French C1
• English C1
Your profile:
• Master’s in engineering, Computer Science, or related technical field
• 5 years+ in validation experience in the biotechnology or pharmaceutical industry
• Proven experience with validation life cycle requirements for cGMPs laboratory systems
• Knowledge of DI requirements and standard regulations for cGMPs operations
Feel free to apply if the position suits you ! Kind regards, Mirella
I manage this role