QA CSV Specialist – 6760 ASH
vor 1 Tag
CTC 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 production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA CSV Specialist for a one year contract role based in the Valais area, Switzerland. QA CSV Specialist – 6760 ASH The focus of the QA CSV Specialist role is to identify or create industry best practices and implement these within the framework of existing GAMP regulations. Responsibilities of the QA CSV Specialist function include both strategic implementation of CSV process improvements and tactical support of CSV operations to meet the changing needs of the business. The role reports into the QA Validations and Qualifications Head at the site. Main Responsibilities: Represent the QA department and act as a liaison between QA CSV and its internal and external customers. Continually monitor industry regulation and trends and apply this knowledge to optimize client policies and procedures for completing a variety of tasks relating to the validation and lifecycle management of computerized systems including process control systems (MES, Delta V), spreadsheets and bench‑top equipment. Provide expert technical IT guidance to the Manager for GMP decisions regarding the validation and lifecycle management of computerized systems. Implement continuous improvements, procedures and local Validation Plans and Master Plans to ensure the department operates efficiently by eliminating activities that do not positively impact production capacity or compliance. Develop project scope, implementation plan and tracking mechanisms quickly, while being forward‑looking to identify roadblocks and solutions prior to issues affecting the project schedule. Audit projects and systems actively to ensure the appropriate validation activities are carried out and are in compliance with regulatory requirements and corporate standards. Evaluate new applications in conjunction with engineering, automation, operations and other departments to identify validation requirements. Act on behalf of, or serve as a conduit to, the QA CSV Manager on CSV issues to ensure that GMP issues are identified and addressed timely and correctly. Qualifications and Experience: Relevant working/residency permit or Swiss/EU‑Citizenship required Bachelor’s degree in Engineering, Information Technologies, Natural Sciences or related. Extensive experience in CSV within the Pharma industry. In‑depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement, as well as the regulatory requirements applicable (GMP Annex 11, 21CFR, GAMP, PICS…). English is mandatory and German is nice to have. Hybrid possibility – 2 days home office. Would you like to learn more about CTC and the opportunity outlined? Please, get in touch with us: you may either use the ‘apply now’ button, write an email, or reach out to us on the phone. Seniority level Mid‑Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing, Biotechnology Research, and Research Services #J-18808-Ljbffr
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