My client based in Redcar is looking to recruit for an IT CSV Specialist, on a permanent basis.

Candidates outside of the immediate Teesside area would be considered as the role can offer hybrid working if preferred.

Main duties of the role will be to coordinate and lead Computer System Validation (CSV) activities to ensure computerised and automation systems and software are in full compliance with regulatory requirements, company policies and procedures. Serve as the subject matter expert to provide compliance guidance and oversight to cross-functional teams CSV projects.

Other duties include, but not limited to:

• Embrace and role model the desired behaviours to exemplify our Company values, promoting an ethical, positive company culture
• To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements
• Preparation and approval of validation documentation or management of the process (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System)
• To monitor project and/or support activities to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes
• To provide and or facilitate quality assurance oversight for the automation of business process associated with pharmaceutical manufacture and distribution
• To project problem identification/resolution/avoidance; typically involving ongoing interaction with management teams within Tech functions, site and local operating company Quality organisations, and Third-Party suppliers/service providers
• To ensure issues/risks are identified, mitigated and/or escalated for items that could adversely impact quality compliance associated with projects/systems
• To ensure the provision of performance measures to drive performance and continuous improvement
• To perform periodic compliance reviews of Tech systems
• Accountable for the validation and validation maintenance of computerised systems associated with Processes, Facilities, Equipment, Manufacturing Execution Systems (MES), and IT systems
• Ensure compliance with GAMP, 21 CFR Part 11, Annex 11, and data integrity requirements

Qualifications: BSc in a Science, Engineering or Computer Science related discipline

Salary: £45-59k depending on experience

Hours: Full time, Mon-Fri. Hybrid option available

Role: Permanent role, immediate start subject to interview

The Recruitment Co is an equal opportunities employer

CPMiddlesbrough

The Recruitment Co. is an equal opportunities employer and we’re committed to diversity and inclusion in the workplace.