CSV Engineer – Pharma Software – Basingstoke – Up to £50k
Our client is a cloud solutions provider to the pharmaceutical and healthcare sectors that develop digital healthcare solutions to enable integrated care throughout the patient journey and prevention of falsified medicines into the supply chain. They have strict requirements for computerised system validation (CSV) and follow a GAMP5-aligned Quality Management System. They are looking for an experienced CSV Engineer to join their team in Basingstoke on a permanent basis.
This role will report to the Quality Manager and will be fully integrated into their Quality Team. Responsibilities include:
- Coordinating validation planning and compliance across the company’s project and operations teams, working closely with project and operations managers.
- Working with internal and customer teams on impact/risk assessment of system changes, deviations and defects. Preparing risk assessments.
- Preparation of validation plans, gate approvals and reports.
- Preparation, formatting, review, approval, distribution and archiving of validation documentation.
- Critical appraisal of validation evidence and documentation to ensure this meets company and customer standards.
- Communicating with customers and suppliers on validation activities, including guidance and agreement on validation approaches.
- Identifying areas where validation processes or documentation can be optimized, automated or improved; coordinating improvement initiatives.
- Preparation and delivery of CSV-related staff training.
- Authoring and development of CSV-related policies, SOPs, templates and work instructions.
- Assisting in internal audits/periodic reviews of validation compliance.
- Leading or assisting in CAPA investigations, root cause analysis, action setting and documentation.
- Assisting in production of quality metrics.
- Assisting in supplier quality audits.
- Have at least three years' experience in a highly regulated (GxP, healthcare or similar) commercial software development or IT service and operations organization, including at least one year in a CSV-related role.
- Have excellent written English and experience of report preparation, proof-reading and formatting.
- Be able to demonstrate working knowledge of GAMP5 and Annex 11 (or similar standards).
- Be technically literate with solid knowledge of the software development life cycle, IT service and operations.
- Be degree educated within a Business or IT-related field.
- ISO 9001, ISO 27001 and/or ITIL experience an advantage.
- Experience with NHS Digital Clinical Safety and Technology Standards an advantage
- Fluent in written and spoken English and eligible to work in the UK
What should you do next?
This CSV Engineer role is one not to be missed; it encompasses the opportunity to be integral within a reputable and growing business. To discuss further, please submit your current CV, or give me a call to find out what other Quality Assurance jobs I'm currently working on.
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Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.