Basel, Full-time
Start Date: ASAP
Duration: 12 months
Contractor Rate: CHF 94.91
The Senior CSV QA Manager will:
• Ensure the compliance of the Computerized system used within the company:
• Provide assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with Company requirements and, where appropriate, in accordance with regulatory requirements
• Determine regulations that are applicable to a computerized system and need for validation
• Apply advanced knowledge and experience to address complex issues
• Review and/or create validation documents where appropriate
• Support efficient integration of the Data Integrity expectations during CSV activities
• Deliver appropriate training to key stakeholders to develop and maintain the CSV and Data Integrity knowledges
• Support CSV QA Team Leader in the preparation of Validation and Data Integrity Master Plan
• Act as a primary contact person between the computerized system project team and Pharmaceutical Development Department
• Provide support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11
• Provide support, guidance and advice with regard to IT Infrastructure qualification to comply with GxP requirements
• Act as the Pharmaceutical Development representative with regard to the update of the internal computerized systems inventory
• Act as Lead Auditor to ensure the compliance along the Computerized system lifecycle:
• Represent Company during internal/external audits
• Perform and coordinate internal and external audits (e.g., vendor audit…) with regard to Computerized System Validation and Data Integrity principles
• Perform and coordinate external audits with regard to IT Infrastructure and services qualification
• Agree on Corrective/Preventive Actions following audits and follow up on adequate execution
Candidate’s Requirements
• Master’s degree / Advanced University degree with suitable qualification in the pharmaceutical industry area
• At least 7 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 in pharmaceutical industry
• 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
