As CSV Manager (m/f/x), you are responsible for managing the IT Validation capability within the IT Assurance function. You are part of the Global IT Organization.
These tasks are waiting for you:
- Collaborate closely with all Global IT departments to ensure that validated environments comply with GMP and other regulatory standards relevant to MedTech
- Oversee, execute, and manage all computer software validation operations within the Global IT organization
- Ensure the preparation, review, and approval of validation documentation, including CSV/CSA risk assessments, change control forms, validation plans, data migration strategies, IQ, OQ, PQ/UAT test protocols and reports
- Conduct an initial Quality Gate assessment when new applications or software are introduced to determine if validation is necessary
- Offer guidance to Global IT projects and programs regarding validation processes
- Conduct audits to verify that governance and change management protocols are properly implemented
This completes your profile:
- Bachelor's degree in Life Sciences, Computer Science, Business, or a related field (or equivalent relevant experience preferred)
- 3+ years of experience in computer system validation, ideally within the Life Science industry
- Familiarity with quality risk management and GxP regulatory frameworks
- Background in project management
- Proven track record working in a global, multi-divisional technology setting
- Strong knowledge and practical application of FDA regulations and other compliance standards
- Fluent English skills and good German skills
This is what the position offers you:
- 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
Information about our client:
The company is a global company focusing on minimally invasive therapies for Medical Devices and Life Sciences with an IT team that is globally connected and drives innovation. They encourage a collaborative environment and are looking for curious personalities to improve people's lives together.
Need more help? Reach out<br></br> to one of our team.
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