Aktuelle Jobs im Zusammenhang mit IT Validation Specialist - Hamburg, Hamburg - Olympus
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IT Validation Specialist
vor 2 Monaten
About the Role
Olympus is seeking a highly skilled IT Validation Leader to join our Global IT organization. As a key member of our team, you will be responsible for designing, implementing, and managing all operational software validation activities.
Key Responsibilities
- Work closely with Global IT functions to ensure the operation of validated environments in accordance with GMP and other regulatory requirements.
- Perform initial Quality Gate Checks for new applications/software to determine validation requirements.
- Provide guidance on validation documentation and requirements to Global IT teams.
- Develop, review, and approve validation documentation, including CSV/CSA Risk Assessments and change control forms.
- Support revalidation processes for major changes and monitor compliance with good practice guidelines and regulations.
- Document compliance and progress towards validation plans.
- Review documentation for projects/products/platforms to ensure governance adherence.
Requirements
- Bachelor's degree in Life Science, Computer Science, or Business (or equivalent experience).
- At least 2 years of experience in validation, preferably in pharmaceutical, biotechnology, clinical, medical, laboratory, or other applicable areas.
- Experience in quality risk management and handling GxP regulations.
- Project management experience, especially with CSV/CSA.
- Progressive experience in a multinational, multidivisional technology environment.
- Good understanding and application of FDA and regulatory requirements.
- English and German language skills.
What We Offer
- 30 days of annual leave.
- Up to 60% mobile work possible + flexible work time model with overtime compensation.
- Holiday and Christmas bonuses.
- Corporate benefits discounts for employees.
- Comprehensive company pension scheme and capital-forming benefits.
- Company restaurant with live cooking and healthy food (subsidized).
- Employee Assistance Program of FamPLUS to support health, mental, and emotional well-being.
- Subsidy for public transportation (Deutschlandticket), free parking spaces, and bike or car leasing.
- Various subsidized company sports groups and access to the inhouse company gym.
