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IT Quality and Compliance Professional

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Sartorius

1mo ago

  • Job
    Full-time
    Senior & Expert Level
  • Software Engineering
    IT & Cybersecurity

AI generated summary

  • You need CSV experience, regulatory knowledge (EMA, FDA, ISO13485), strong IT and SAP understanding, GAMP5 familiarity, clear communication skills, and a relevant degree. Fluent English is required.
  • You will validate applications, develop documents, support stakeholders, manage relationships, qualify suppliers, train personnel, and oversee change control and 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
  • University degree in information technology or a comparable qualification
  • Professional Expertise in validation and infrastructure qualification
  • Fluent business English (level B2/1)

Responsibilities

  • 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.

FAQs

What key responsibilities does the IT Quality and Compliance Professional have?

The key responsibilities include application validation, development of validation documents, supporting system and process owners, managing stakeholder relationships, CSV supplier qualification, training personnel on validation topics, and overseeing change control and periodic reviews.

What experience is required for this role?

Several years of professional experience in computerized system validation (CSV) including data integrity is required, with practical experience in application validation according to relevant regulations and guidelines such as EMA, FDA, ISO13485, GMP, GAMP5, and CSA.

Which regulations and guidelines should the candidate be familiar with?

The candidate should be familiar with EMA, FDA, ISO13485, GMP, GAMP5, and CSA regulations and guidelines.

Is knowledge of specific IT systems required?

Yes, an excellent understanding of IT systems and landscape, including SAP knowledge, is required.

What kind of skills are essential for this position?

Strong interpersonal communication skills, the ability to write clear documentation, and the capability to communicate complex information simply and accurately to various stakeholders are essential.

What educational qualifications are needed for this role?

A university degree in information technology or a comparable qualification is required.

Is proficiency in other languages necessary for this position?

Fluent business English (level B2/1) is required for effective communication.

Will the candidate have the opportunity to support training?

Yes, the candidate will be responsible for supporting the training of personnel on validation topics.

What qualifications should a candidate have in validation and infrastructure?

The candidate should possess professional expertise in validation and infrastructure qualification.

How important is experience with cloud infrastructure and AI validation?

Experience in cloud infrastructure qualification and AI validation is considered vital as part of the several projects the candidate will work on.

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Sartorius

A Trusted Partner for the Biopharmaceutical Industry and Laboratories

Science & Healthcare
Industry
10,001+
Employees
1870
Founded Year

Mission & Purpose

As a fast growing global life science company and a dynamic industry leader, Sartorius is the go-to place for ambitious people who want to move things forward: We offer you the chance to grow with us and to become part of the solution in the fight against diseases that are yet incurable or untreatable. Our ambition is to simplify medical progress from the first idea of a new medication to its production. We support our customers with innovative technologies that make the development and manufacture of new therapeutics faster and more efficient. So that more people have access to better medicine. More than 15,000 employees at over 60 production and sales locations worldwide are committed to this vision. And we are looking for more people who share this ambition and want to make a contribution.