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CSV Manager
vor 2 Monaten
As a CSV Manager, you will play a crucial role in ensuring the IT Validation capability within the IT Assurance function is running smoothly. You will be part of the Global IT Organization, working closely with various departments to ensure compliance with GMP and other relevant regulatory standards.
Key Responsibilities:- Collaborate with Global IT departments to ensure validated environments meet regulatory standards
- Oversee, execute, and manage computer software validation operations within the Global IT organization
- Prepare, review, and approve validation documentation, including CSV/CSA risk assessments, change control forms, requirements, validation plans, data migration strategies, IQ, OQ, PQ/UAT test protocols and reports
- Conduct Quality Gate assessments for new applications or software to determine if validation is necessary
- Provide guidance to Global IT projects and programs regarding validation processes
- Conduct audits to verify governance and change management protocols are properly implemented
- Bachelor's degree in Life Sciences, Computer Science, Business, or a related field (or equivalent relevant experience)
- 3+ years of experience in validation, ideally within the Life Science industry
- Familiarity with quality risk management and GxP regulatory frameworks
- Background in project management, particularly in the context of CSV/CSA
- Proven track record working in a global, multi-divisional technology setting, with expertise in planning, forecasting, modeling, and analysis
- Strong knowledge and practical application of FDA regulations and other compliance standards
- Fluent English skills and good German skills
- Flexible working hours
- A comprehensive company pension scheme
- Regular training courses
- Free parking or a ticket for the Hamburg public transport network
- Health care and medical check-ups
- A staff restaurant and subsidized lunches
- 30 days of holiday time each year
About Our Company:
We are a global company focusing on Medical Devices and Life Sciences with an IT team that is globally connected and drives innovation. We encourage a collaborative environment and are looking for curious personalities to improve people's lives together.
