The IT Quality and Compliance Professional will be responsible for ensuring compliance standard of the IT landscape. Additionally, the compliance standards need to be update according to international regulation and guidelines if updates of them are available.
Responsibilities
Responsibilities will include, but not limited to, the following:-
Responsible for application validation including data integrity.
Development of validation documents e.g. validation plans, user requirements specifications (URS), functional specifications (FS), risk assessments, test plans, traceability matrixes and reports in line with corporate guidelines procedures and regulations.
As a Subject Matter Expert (SME), should support System Owner and Process Owners.
Manage relationships with various stakeholders, give guidance and lead workshops e.g. for data integrity assessments
Responsible for CSV supplier qualification
Support training of personnel on validation topics
Change Control, Periodic Reviews
Requirements:
Several years of professional experience in computerized system validation (CSV) incl. data integrity in several projects: e.g. cloud infrastructure qualification, AI validation.
Practical experience in the application validation according to relevant regulations and guidelines (EMA, FDA, ISO13485, GMP, GAMP5, CSA)
Excellent understanding of IT systems and landscape incl. SAP knowledge
Good understanding of GAMP5 processes as well as business processes
Strong interpersonal communication skills
Ability to write clear documentation and communicate complex information simply and accurately to various stakeholders on different levels e.g. from business, quality and IT
Qualifications & Skills:
University degree in information technology or a comparable qualification
Professional Expertise in validation and infrastructure qualification
Fluent business English (level B2/1)
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers