Ihre Aufgaben
- 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
Ihre Qualifikationen
- Bachelor’s degree in Life Science, Computer Science or Business (or equivalent and related experience preferred)
- At least 2 years 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
Ihre Vorteile
-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 inhouse company gym