CSV Expert

vor 3 Monaten

Bern, Schweiz Consultys Vollzeit

Perform CSV activities associated with ensuring that business processes required to operate a highly automated & integrated large-scale bio-production facility are qualified and maintained in a validated stateProvide input on improvement of testing documentationSupport the implementation and adoption of the global CSV program and remediationSupport data integrity implementation and remediation for systems within the CSV programParticipate in audits and continuous improvement effortsWork with other members of IT and Site organizations to ensure that Computerized System Validation packages are consistent with validation plans and standard operating proceduresMaster's Degree or Bachelor's preferably in Computer Science, Life Sciences, Engineering, Biotechnology, Automation and10 years of experience in CSV in the Pharma or Biotech industryGreat understanding of CSV regulations such as FDA’s 21 CFR Part 11, EMA’s Annex 11Experience in modern and risk-based validation executionsBackground in Pharma/Biotech industriesDirect experience with LIMS or Laboratory systems is a plusFluency in English

  • CSV Validation Specialist

    vor 3 Wochen

    Bern, Bern, Schweiz Capgemini Vollzeit

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  • Cqv / Csv Consultant

    vor 3 Monaten

    Bern, Schweiz Consultys Vollzeit

    As part of our development, we are recruiting a CQV/CSV Consultant to join our teams. - Assess laboratory instruments and software for their compliance with Data Integrity guidelines. - Implement Data Audit Trail Reviews for laboratory instruments and software in accordance with client guidelines. - Manage local and global qualification and validation...

  • Computer System Validation Expert

    vor 2 Monaten

    Bern, Bern, Schweiz Capgemini Vollzeit

    About Capgemini EngineeringAt Capgemini Engineering, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal growth.Job DescriptionKey ResponsibilitiesAssess and produce the CSV...

  • Global Category Lead

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryCSL Behring is seeking a highly experienced and skilled Global Category Lead to join our team. As a key member of our procurement organization, you will be responsible for leading multiple global Category Management teams and overseeing the development and execution of category management strategies across the entire CSL group.Key...

  • Associate Engineer System Lifecycle

    Vor 3 Tagen

    Bern, Schweiz Randstad - Medium prio Vollzeit

    JobdescriptionAssociate Engineer System Lifecycle (f/m/x)The Engineer System Lifecycle collaborates closely with other departments to ensure the system functionality in routine and extra-routine phases, involving the Suppliers to implement improvements or problem fixing, and leading or supporting quality investigations and remediations. He/She is the...

  • Sr Team Leader System Life Cycle

    vor 5 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    For our growing site in Bern we are currently recruiting a **Systems Lifecycle Sr Team Leader **to join our team. The **Systems Lifecycle Sr Team Leader **supervises a team of individual contributors in the execution of the System Lifecycle Process for the simple GMP systems in Bern, acting as System Owner, Subject Matter Expert and Single Point Of Contact...

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    vor 3 Wochen

    Bern, Schweiz Pharmiweb Vollzeit

    Get ready to redefine what's possible and discover your extraordinary potential. Here at Labcorp, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own...