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
Represents the QA department and act as a liaison between QA CSV and its internal and external customers
Continually monitors industry regulation and trends and applies this knowledge to optimize clients 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
Responsible for implementing continuous improvements, procedures and local Validation Plans and Master Plans to ensure the department is operating as efficiently as possible by eliminating activities that do not positively impact production capacity or compliance
Capable of quickly developing a project scope, implementation plan and tracking mechanisms, while being forward looking to identify roadblocks and solutions prior to issues affecting the project schedule
Actively audit projects and systems to ensure that the appropriate validation activities are carried out and are in compliance with regulatory requirements & corporate standards
In conjunction with engineering, automation, operations and other departments, evaluate new applications in order to identify validation requirements
Act on behalf of, or be 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.
5-10 years of CSV experience in Pharma industry
Experience and 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 contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.
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