QA Validation Engineer

vor 4 Wochen


Orbe, Waadt, Schweiz Axepta SA Vollzeit
Job Title: QA Validation Engineer - CSV

We are seeking a highly skilled QA Validation Engineer - CSV to join our team at Axepta SA. As a key member of our quality assurance team, you will be responsible for ensuring the compliance of automated and computerized systems with cGMP and applicable regulations.

Key Responsibilities:
  • Act as the main point of contact for all quality compliance key topics regarding Automated and Computerized systems (MES, EBR, PLC/SCADA, EMS, LIMS, ERP systems)
  • Review and approve the URS and relevant design documentation
  • Support actively the risk assessment exercises
  • Review and approve Computerized and Automated (SISA) systems related documentation (procedures, FAT/SAT protocols and reports, qualification protocols and reports, CAPAs, deviations and change controls) to ensure compliance with cGMP and applicable regulations
  • Support the Commissioning & Qualification activities
  • Create SOPs for Automated and Computerized systems qualification / validation including 21CFR part 11 and data integrity requirements
  • Perform quality audits for computerized and automated systems suppliers if needed
  • Ensure qualification and validation of all systems in close collaboration with process engineering & automation teams
Requirements:
  • Must speak English and French
  • Must have minimum of 5 years in a quality assurance engineering role in a biopharmaceutical manufacturing environment / medical devices
  • Experience in computerized and automated systems (MES, PLC SCADA systems, EMS, LIMS, ERP systems)
  • Experience in health authorities inspections

We offer a dynamic and challenging work environment, and we are committed to supporting the growth and development of our employees. If you are a motivated and experienced QA Validation Engineer - CSV looking for a new challenge, please submit your application.



  • Orbe, Waadt, Schweiz AXEPTA SA Vollzeit

    Job Title: QA Validation Engineer - CSVWe are seeking a highly skilled QA Validation Engineer - CSV to join our team at AXEPTA SA. As a key member of our quality assurance team, you will be responsible for ensuring the compliance of our automated and computerized systems with regulatory requirements.Key Responsibilities:Act as the primary point of contact...


  • Orbe, Waadt, Schweiz Axepta SA Vollzeit

    We are looking for a Senior Validation Engineer - CSV to join our team at Axepta SA. As a key member of our quality assurance department, you will be responsible for ensuring the compliance of our automated and computerized systems with cGMP and applicable regulations.Main Responsibilities:Act as the main point of contact for quality compliance key topics...


  • Orbe, Waadt, Schweiz Axepta SA Vollzeit

    Job Responsibilities:As a QA Validation Engineer - CSV for Axepta SA, you will be the main point of contact for all quality compliance key topics related to Automated and Computerized systems. Your responsibilities will include reviewing and approving URS and relevant design documentation, actively supporting risk assessment exercises, and reviewing and...


  • Orbe, Waadt, Schweiz Randstad Vollzeit

    Job DescriptionWe are seeking a Senior Quality Assurance Specialist to join our team at Randstad. The ideal candidate will have a strong background in quality assurance and a deep understanding of computerized systems validation and data integrity.ResponsibilitiesAs a Senior Quality Assurance Specialist, you will be responsible for managing quality oversight...


  • Orbe, Waadt, Schweiz Randstad Vollzeit

    Job DescriptionWe are seeking a Senior Quality Assurance Specialist to join our team at Randstad. As a key member of our quality assurance team, you will be responsible for managing quality oversight for computerized systems validation and data integrity programs. Your expertise will ensure compliance with quality policies, cGMP, EU/US, and Swiss...


  • Orbe, Waadt, Schweiz Axepta SA Vollzeit

    Job Description:As a Quality Assurance Engineer - CSV - Permanent Position at Axepta SA, you will be responsible for ensuring the quality and compliance of automated systems in the biopharmaceutical field. Your main tasks will include reviewing and approving URS and design documentation, supporting risk assessment exercises, and reviewing and approving...

  • QA CSV Engineer

    vor 1 Monat


    Orbe, Schweiz AXEPTA SA Vollzeit

    QA CSV EngineerFor our client, a growing biopharmaceutical company based in Vaud canton, we are currently looking for a QA Validation Engineer - CSV. This is a permanent position  YOUR RESPONSIBILITIES: • Act as the main point of contact for all quality compliance key topics regarding Automated and Computerized systems (MES, EBR, PLC/SCADA, EMS, LIMS,...


  • Orbe, Schweiz AXEPTA SA Vollzeit

    QA CSV EngineerFor our client, a growing biopharmaceutical company based in Vaud canton, we are currently looking for a QA Validation Engineer - CSV. This is a permanent position  YOUR RESPONSIBILITIES: • Act as the main point of contact for all quality compliance key topics regarding Automated and Computerized systems (MES,...


  • Orbe, Schweiz Axepta SA Vollzeit

    For our client, leader in the biopharmaceutical field, is currently looking for a QA Validation Engineer - CSV - Permanent position YOUR RESPONSIBILITIES: • Act as the main point of contact for all quality compliance key topics regarding Automated and Computerized systems (MES, EBR, PLC/SCADA, EMS, LIMS, ERP systems)• Review and approve the URS and...

  • Qa Csv Engineer

    vor 1 Monat


    1350 Orbe, Schweiz AXEPTA SA Vollzeit

    For our client, a growing biopharmaceutical company based in Vaud canton, we are currently looking for a QA Validation Engineer - CSV. This is a permanent position  YOUR RESPONSIBILITIES: • Act as the main point of contact for all quality compliance key topics regarding Automated and Computerized systems (MES, EBR, PLC/SCADA, EMS, LIMS, ERP...


  • 1350 Orbe, Schweiz AXEPTA SA Vollzeit

    For our client, a growing biopharmaceutical company based in Vaud canton, we are currently looking for a QA Validation Engineer - CSV.  This is a permanent position    YOUR RESPONSIBILITIES:   • Act as the main point of contact for all quality compliance key topics regarding Automated and Computerized systems (MES, EBR,...

  • Senior Quality Assurance

    vor 3 Monaten


    Orbe, Schweiz Randstad Vollzeit

    JobdescriptionFor our client based in Vaud canton and specializedin biopharmaceutical area, we’re looking for a Senior QualityAssurance - CSV specialist ResponsabilityManageQuality oversight for computerized systems validation and the dataintegrity program & support QA activities for systemintroduction/upgrades, ensuring compliance with quality...