IT Quality Assurance & CSV Manager (German Speaking)

Helvetica Partners Sarl

Posted on May 17, 2024 by Helvetica Partners Sarl
Solothurn, Switzerland
IT
Immediate Start
Annual Salary
Full-Time

We are currently looking on behalf of one of our important clients for an IT Quality Assurance & CSV Manager (German Speaking). The role is a permanent position based in Solothurn Canton & comes with some home office allowance.

Your Role:

  • Carry out personnel, technical & people life cycle management of a IT QA & CSV team.
  • Act as a key contact person & all-rounder in the field of IT Quality Assurance & Computer Systems Validation.
  • Advise & support system owners, project managers or suppliers in the validation of computer systems according to internal & external GxP/GAMP specifications (eg in the field of production systems SW, SW development, MES or database systems).
  • Independently prepare the necessary documentation & execution of tests.
  • Support the continuous development of IT processes (eg further development of internal CSV processes or certification of IT service areas according to ISO 27001: Information Security).
  • Act as a key contact person as a CSV expert for customers & audits.
  • Review & approval CSV & system documentation.

Your Skills:

  • At least 5 years of relevant professional experience including experience in IT Quality Assurance, Computer Systems Validation & Computer Software Assurance.
  • A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure.
  • Experienced with Q-Systems (eg EU: Annex 11/FDA: 21CFR Part 11).
  • Ideally experienced in the Medical Technology Sector.
  • A knowledge of important IT Standards & Methods (eg ISO27001, ISO 80002-2, ITIL) or ISO 13485:2016 QMS for Medical Devices.

Your Profile:

  • Completed relevant Scientific or Technical University Degree.
  • Strong communication skills, assertive & highly quality-oriented.
  • Fluent English & good German language skills (to at least B2 Level) are a mandatory requirement.

Reference: 2762126137

https://jobs.careeraddict.com/post/91063970

This Job Vacancy has Expired!

Helvetica Partners Sarl

IT Quality Assurance & CSV Manager (German Speaking)

Helvetica Partners Sarl

Posted on May 17, 2024 by Helvetica Partners Sarl

Solothurn, Switzerland
IT
Immediate Start
Annual Salary
Full-Time

We are currently looking on behalf of one of our important clients for an IT Quality Assurance & CSV Manager (German Speaking). The role is a permanent position based in Solothurn Canton & comes with some home office allowance.

Your Role:

  • Carry out personnel, technical & people life cycle management of a IT QA & CSV team.
  • Act as a key contact person & all-rounder in the field of IT Quality Assurance & Computer Systems Validation.
  • Advise & support system owners, project managers or suppliers in the validation of computer systems according to internal & external GxP/GAMP specifications (eg in the field of production systems SW, SW development, MES or database systems).
  • Independently prepare the necessary documentation & execution of tests.
  • Support the continuous development of IT processes (eg further development of internal CSV processes or certification of IT service areas according to ISO 27001: Information Security).
  • Act as a key contact person as a CSV expert for customers & audits.
  • Review & approval CSV & system documentation.

Your Skills:

  • At least 5 years of relevant professional experience including experience in IT Quality Assurance, Computer Systems Validation & Computer Software Assurance.
  • A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure.
  • Experienced with Q-Systems (eg EU: Annex 11/FDA: 21CFR Part 11).
  • Ideally experienced in the Medical Technology Sector.
  • A knowledge of important IT Standards & Methods (eg ISO27001, ISO 80002-2, ITIL) or ISO 13485:2016 QMS for Medical Devices.

Your Profile:

  • Completed relevant Scientific or Technical University Degree.
  • Strong communication skills, assertive & highly quality-oriented.
  • Fluent English & good German language skills (to at least B2 Level) are a mandatory requirement.

Reference: 2762126137

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