CSV Consultant

Responsibilities
• Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
• Working as a seconded PM Group resource in a client-led team.
• Working with client subject matter experts and automation analysts in supporting technical elements of the project.
• Leading CSV elements of new laboratory equipment installation.
• Leading CSV decisions, determining CSV requirements, advising the business on CSV practices, sharing CSV knowledge with the team.
• Validating the introduction of new systems and providing data integrity risk assessments for each.
• Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits.
Qualifications & Requirements
Applicants will have experience of computerised systems validation on multiple projects in the pharmaceutical sector, particularly in relation to working on research and development facilities. Successful candidates will be able to demonstrate technical competence, will be able to work efficiently and safely, and will be willing to supervise and train others in any specialist areas of which the candidate is knowledgeable. The roles require delivery of results on time, in accordance with client standards and health and safety procedures