IT Validation Manager
vor 3 Wochen
We are seeking an experienced IT Validation Manager to join our team at Olympus Medical Systems EMEA. As a key member of our Global IT organization, you will be responsible for designing, implementing, and managing operational software validation activities.
Key Responsibilities- Validation Strategy and Planning
- Develop and implement validation strategies to ensure compliance with regulatory requirements, such as GMP and ISO standards.
- Collaborate with cross-functional teams to plan and execute validation activities.
- Validation Execution and Management
- Lead the execution of validation activities, including risk assessments, testing, and documentation.
- Manage and maintain validation documentation, including CSV/CSA risk assessments, change control forms, and requirements traceability matrices.
- Compliance and Governance
- Ensure compliance with regulatory requirements and company policies.
- Review and approve validation documentation to ensure adherence to governance guidelines.
- Stakeholder Management
- Communicate with stakeholders, including project managers, developers, and quality assurance teams.
- Provide guidance and support to teams on validation processes and procedures.
- Education
- Bachelor's degree in Life Science, Computer Science, or Business (or equivalent and related experience).
- Experience
- At least 2 years of experience in validation, preferably with a focus on pharmaceutical, biotechnology, clinical, medical, laboratory, or other applicable areas.
- Experience in quality risk management and handling GxP regulations.
- Experience in project management, especially with regards to CSV/CSA.
- Skills
- Good understanding and application of FDA and regulatory requirements.
- English and German language skills.
Olympus Medical Systems EMEA values diversity and inclusion. We encourage all qualified individuals to apply, regardless of gender, restrictions, nationality, ethnic and social origin, religion, world view, age, or sexual orientation and identity.
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