Jobbeschreibung
At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Within the Olympus Corporation, Olympus Surgical Technologies Europe (OSTE) is the global competence center for development, production and repair services for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of about 3,600 employees at 14 locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical technology and therapy and offers a full range of the most modern endoscopic applications from single products to procedure-oriented system solutions.
- 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 creation of a medical device through to authorization to ISO standards (e.g., GMP, GCP, MDR, etc.)
- Document compliance and progress towards the validation plan
- Review documentation for projects/products and platforms to ensure governance is adhered to by the external and internal teams
- Manage spot check audits to ensure projects/products/platforms change governance is adhered to
- Bachelor's degree in Life Science, Computer Science or Business or equivalent, related experience preferred
- Several years' experience in validation, preferably with a focus on pharmaceutical, biotechnology, clinical, medical, laboratory or other applicable area
- Experience in quality risk management and handling GxP regulations
- Experience in project management, especially with regards to CSV/CSA
- Progressive experience in a multi-national, multi-divisional technology environment with demonstrated experience in planning, forecasting, modeling and analysis
- Good understanding and application of FDA and regulatory requirements
- English and German language skills
- 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 your 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 in-house company gym