It Quality And Compliance Professional Job in Sartorius

IT Quality and Compliance Professional

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)