Quality Specialist – CSV (Computer Systems Validation)

Zoek Pin Sawston, Cambridgeshire, England

Permanent (Full time)

Posted 12 days ago

Do you have Quality / QA experience gained in a commercial Biopharmaceutical organisation? Do you have an aptitude for computer systems and data, and an interest in developing your career within Computer Systems Validation (CSV)? If so, this will be the ideal opportunity to join a growing cell therapy business and gain first-hand experience of CSV.

This is a permanent role with a cell therapy company located just South of Cambridge, Cambridgeshire, as a Computer System Validation Specialist. The ideal candidate will have a scientific or technical degree together with some understanding of validating computer systems (LIMS, or BMR, QMS, monitoring systems) or equipment in a GMP environment according to GAMP. This is a great opportunity developing and progressing in a growing organisation.

The role is full-time Monday to Friday, primarily based on site with occasional ad hoc opportunities to work from home. The facility has excellent transport links and you will be surrounded by a supportive, collaborative team.

The Role : Based in a team of 6, you will be responsible for managing the validation aspects of projects including scheduling work, agree timeline and liaise with other departments. You will be performing computer system validation activities on equipment, facilities and laboratory systems and manage multiple tasks to provide solutions to complex problems. You will be required to author, execute, and report validation activities according to GMP and QMS requirements. Working in a fast-paced, highly process-driven manufacturing environment, you will encounter a range of technical challenges and opportunities to collaborate with scientific, engineering, quality, and production teams.

Experience : The successful candidate will be a conscientious, attentive individual with experience in GMP from a role in ideally Computer Systems Validation (or similar), according to GAMP, ideally from the biopharmaceutical, ATMP or related industry. You will ideally have a degree in a Scientific discipline or equivalent experience. You must have a good understanding of manufacturing processes, laboratory equipment and computer systems. You must be able to demonstrate reviewing documents and data, writing quality reports as well as ensuring the meticulous checking and qualification of equipment or computer systems. You will need excellent communication and team working skills, with the ability to handle your own workload, organize your own time and follow Standard Operating Procedures (SOPs).

Full details will be provided on application

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