CSV engineer

Proclinical Limited
Paris Island Little
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
ProClinical is currently working as resourcing partner with a TOP 5 global pharma company based in Switzerland who is actively looking for CSV engineer and Design Qualification protocols for 3 years of project with the first employment with 12 months of rolling contract. The CSV lead will coordinate the validation of GMP relevant computer systems with internal and external, global and local guidelines and regulations, this specific role will be based in France. Job Responsibilities: - Ensure that adequate standards are maintained, communicated and effectively implemented for all systems and associated computer infrastructure - Consult and advise computer systems projects on the correct application of internal and external regulations - Audit computerized systems at the site and monitor the implementation of corrective and preventive action plans. - Ensure that the internal regulations are in line with up to date regulatory requirements. - Decides the minimum level of qualification and validation necessary for local systems to ensure compliance with all relevant regulations and industry guidance documents, as well as internal local and global regulations - Provides expert technical IT guidance to the Head of Quality for GMP decisions regarding the validation of computerized systems - Ensure that the requirements for the validation of local computerized systems are clearly defined in policies, standards, VMPs, and standard operating procedures - Ensure that the requirements for the validation of computerized systems are communicated effectively to engineering, controls, QC, IT, QA and other relevant personnel, including system owners, within the Lonza organization - Coordinate the validation of computer systems ensuring that appropriate actions are carried out and recorded in accordance with approved documented procedures and in compliance with regulatory requirements and Corporate Quality Standards - Ensure that the change management process for evaluating new or revised software is implemented and that the appropriate validation activities are identified and carried out - Participate as the quality representative on steering committees for all CSV and core business process projects to ensure that the necessary validation activities are identified and carried out - Actively audit projects and systems to ensure that the appropriate validation activities are carried out in compliance with regulatory requirements & corporate standards - In conjunction with engineering, controls, IT and other departments, evaluate new applications to identify validation requirements - Act on behalf of, or be a conduit to, the Head of Quality on CSV issues to ensure that GMP issues are identified and addressed - Familiarity with cGMPs, GAMP, ICH Q7A and basic validation practices (IQ/OQ/PQ) - Understanding of the following computer systems: Programmable Logic Controllers (PLCs), Distributed Control Systems (DCS), Supervisory Control and Data Systems (SCADA), and PC based computer systems hardware and software To Apply: Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Ivan Gitardi on **************** or upload your CV on our website - *******************. A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
This job was originally posted as www.jobsite.co.uk/job/959199841