QA CSV Specialist
Vor 2 Tagen
Do you thrive on ensuring every system meets rigorous validation standards while empowering a CMO's vision? Proclinical is seeking a QA CSV Specialist to support the validation and lifecycle management of computerized systems within a regulated environment. This role focuses on implementing industry best practices in alignment with GAMP regulations, driving process improvements, and providing technical guidance for compliance. You will work closely with cross-functional teams to ensure operational efficiency and regulatory adherence. Please note that to be considered for this role you must have the right to work in this location or hold an EU passport. Responsibilities: Act as a liaison between QA CSV and internal/external stakeholders. Monitor industry regulations and trends to optimize policies and procedures. Oversee validation and lifecycle management of computerized systems, including process control systems, MES, Delta V, spreadsheets, and bench-top equipment. Provide expert IT guidance for GMP decisions related to computerized systems. Implement continuous improvement initiatives and develop local Validation Plans and Master Plans. Manage system lifecycle deliverables from commissioning and qualification to system retirement. Ensure compliance with regulatory requirements such as GMP Annex 11, 21 CFR, GAMP, and PICS. Develop project scopes, implementation plans, and tracking mechanisms while proactively addressing potential roadblocks. Audit projects and systems to verify appropriate validation activities and compliance. Collaborate with engineering, automation, and operations teams to evaluate new applications and identify validation requirements. Represent or support the QA CSV Manager on CSV-related issues to address GMP concerns effectively. Key Skills and Requirements: Bachelor's degree in Engineering, Information Technologies, Natural Sciences, or a related field. Proficiency in English; knowledge of German is an advantage. Strong understanding of system lifecycle deliverables and regulatory requirements (e.g., GMP Annex 11, 21 CFR, GAMP, PICS). Experience in project management, including developing project scopes, plans, and tracking mechanisms. Ability to identify and implement process improvements to enhance efficiency and compliance. Familiarity with computerized systems such as MES, Delta V, and process control systems. Strong communication and collaboration skills to work effectively with cross-functional teams.
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QA CSV Specialist
vor 2 Wochen
Visp, Schweiz Gi Group VollzeitQA CSV Specialist (m/f/d) 📄 Contract: Temporary - 1 year Summary: The QA CSV Specialist plays a key role in defining and implementing industry best practices for Computer System Validation (CSV) within the framework of GAMP regulations. This position combines strategic initiatives to improve CSV processes with hands‑on support for operational...
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QA CSV Specialist
vor 3 Wochen
Visp, Schweiz Randstad (Schweiz) AG VollzeitJobdescription QA CSV Specialist For our Client in Visp we are searching for a Computer System Validation Specialist/Engineer (CSV) to carry out a variety of tasks related to the validation and lifecycle management of computerized systems Key Responsibilities: - Identify or create industry best practices and implement these within the framework of existing...
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QA CSV Specialist – 6760 ASH
vor 1 Woche
Visp, Schweiz CTC Resourcing Solutions VollzeitCTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed. Our client, a global market leader in the...
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QA CSV Specialist
vor 3 Wochen
Visp, Schweiz Actalent VollzeitJoin the team as a QA CSV Specialist and play a key role in ensuring compliance and driving continuous improvement in computerized system validation (CSV) processes. Duration: 1 year Home Office: 2 days Your Responsibilities Represent QA and act as liaison for CSV-related topics. Implement and optimize validation processes in line with GAMP, GMP Annex 11, 21...
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QA Specialist, CSV
vor 5 Stunden
Visp, Schweiz Experis Schweiz VollzeitFor our pharmaceutical client based in Visp, we are currently seeking an experienced QA Specialist, CSV & Automation to support large-scale CAPEX projects within a GMP-regulated manufacturing environment. Description The "QA Specialist, CSV & Automation" is responsible for the qualification and validation compliance of equipment and computerized systems...
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QA CSV Specialist
Vor 5 Tagen
Visp, Valais, Schweiz Hays VollzeitTheQA CSV Specialistplays a key role in ensuring compliance and efficiency in the validation and lifecycle management of computerized systems. Reporting to the QA Validations & Qualifications Head, this position combines strategic process improvement with hands-on operational support, ensuring systems meet both regulatory requirements and business...
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QA CSV Specialist
vor 4 Wochen
Visp, Schweiz Proclinical Group VollzeitDo you thrive on ensuring every system meets rigorous validation standards while empowering a CMO's vision? Proclinical is seeking a QA CSV Specialist to support the validation and lifecycle management of computerized systems within a regulated environment. This role focuses on implementing industry best practices in alignment with GAMP regulations, driving...
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QA CSV Specialist
vor 2 Wochen
Visp, Schweiz Proclinical Staffing VollzeitDo you thrive on ensuring every system meets rigorous validation standards while empowering a CMO's vision? Proclinical is seeking a QA CSV Specialist to support the validation and lifecycle management of computerized systems within a regulated environment. This role focuses on implementing industry best practices in alignment with GAMP regulations, driving...
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Hybrid QA CSV Specialist – Pharma
vor 1 Woche
Visp, Schweiz CTC Resourcing Solutions VollzeitA leading recruitment partner in Life Sciences is seeking a QA CSV Specialist for a one-year contract in the Valais area, Switzerland. The role requires extensive experience in CSV within the Pharma industry, focusing on implementing best practices in compliance with GAMP regulations. Responsibilities include acting as a liaison for QA CSV, monitoring...
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Hybrid QA CSV Specialist — Pharma/GAMP
vor 2 Wochen
Visp, Schweiz Gi Group VollzeitA recruitment agency is seeking a QA CSV Specialist in Switzerland. This contract role involves ensuring compliance with regulation and managing CSV processes effectively within the pharmaceutical sector. The ideal candidate will have a Bachelor's degree and extensive experience in the industry, coupled with strong project management and communication...
