Tasks

- Ensuring the compliance of the Computerized system used within the company
- Experince working with SAP, Data migration and implementaion of systems
- Providing assurance in the GxP regulated computerized systems
- Reviewing and/or creation of validation documents where appropriate
- Supporting efficient integration of the Data Integrity expectations during CSV activities
- Training to key stakeholders to develop and maintain the CSV and Data Integrity knowledges
- Partivipating and Supporting in the preparation of Validation and Data Integrity Master Plan
- Support, guidance and advice regarding to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11
- Act as Lead Auditor to ensure the compliance along the Computerized system lifecycle: internal, external
- Supporting in the preparation and the management of QS Documents relating to CSV QA and Data Integrity activities

Qualifications

• Master’s degree / Advanced University degree with suitable qualification in the pharmaceutical industry area
• At least 5 years experience in Computerized Systems Validation (CSV)
• Good knowledge and understanding of regulatory requirements such as GxP & 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11
• Good knowledge and understanding of Data Integrity expectations and regulations
• Excellent written and verbal communication and interpersonal skills
• Ability to work under pressure and prioritize tasks
• Fluent in English, German and/or French are an advantage
• Ability to work as an individual or as part of a team
• Reliable and conscientious