Olympus Corporation
Website:
olympus-global.com
Job details:
As an IT validation specialist, you are responsible for supporting the management of system and software validation checks of systems against regulatory requirements. You will assist in monitoring the compliance of system adherence to good practice guidelines and regulations. You will also work closely with the QARA domain, who will be assisting in the conduct of validation software/systems.
Main Responsibilities
Development of a Global Validation Framework
- Assist in developing the cross-regional software validation strategy of utilizing and leveraging support from a third party/external resources.
- Review and validate third-party vendors/external resources to create a partnership to support the cross-regional validation strategy.
- Assist in developing and managing the IT validation roadmap to ensure efficient and effective resource management against the validation activities required across all regions.
IT Validation
- Design, implement, and manage all operational software validation activities within the Global IT organization.
- Work closely with all Global IT functions to ensure the operation of validated environments (according to GMP and other regulatory requirements relevant to a MedTech company).
- Perform the initial Quality Gate Check when a new application/software is introduced to determine whether the software needs to be validated or not.
- Provide guidance to Global IT teams on the process for the creation of validation documentation and requirements.
- Ensure the development, review, and approval of validation documentation including CSV/CSA risk assessments, change control forms, requirements, validation plans, data migration plans, IQ, OQ, PQ/UAT test protocols, test cases and reports, and requirements traceability matrices.
- Provide expertise and advice to Global IT programs and projects on validation.
- Support the revalidation process in the event of a major change.
- Monitor the compliance of system adherence to good practice guidelines and regulations from the creation of a medical device through to authorization to ISO standards (e.g., GMP, GCP, MDR, etc.).
- Liaise with the QARA domain to provide updates on the execution and outputs of the validation conducted for software/systems.
- Document compliance and progress towards the validation plan.
Change Management
- Review documentation for projects/products and platforms to ensure governance is adhered to by the external and internal teams.
- Take part in scheduled CAB sessions and provide feedback on adherence to regulatory compliance.
- Provide an overview to ensure changes implemented are following IT change governance processes.
- Manage spot check audits to ensure projects/products/platforms change governance is adhered to.
Why work at Olympus?
At Olympus, we are committed to fostering a high-performing culture, a collaborative environment, and empowering everyone to shine. Our shared values—integrity, empathy, long-term view, agility, and unity—form the foundation of our culture and guide our behavior. These values ensure that our people feel they are making a meaningful difference every single day.
What we are looking for:
Education:
- Bachelor’s degree in life science, computer science, or business (or equivalent and related experience preferred).
Experience
- At least 3 years 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 regard to CSV/CSA.
- Progressive experience in a multinational, multidivisional technology environment with demonstrated experience in planning, forecasting, modeling, and analysis.
- Good understanding and application of FDA and regulatory requirements.
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Want to know more?
Confidential discussions are welcome; contact our TA Partner.
Olympus is an Equal Opportunity Employer.
"We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a nondiscriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply
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