CSV Lead

PE Global is currently recruiting for a CSV Lead for an initial 12-month contract role with a leading multinational pharmaceutical client based in Runcorn.

Job Responsabilities:

• Establish the validation and compliance strategies and approaches within the site local projects
• Ensure adherence to company standards and applicable regulatory requirements and practices
• Advise on Data Integrity
• Validate manufacturing systems, Laboratory Systems and Business Systems
• Work under pressure and to strict deadlines
• Provide weekly updates to the CSV Manager and escalate any issues as they occur
• Maintain, develop, implement and monitor site policy and procedures for CSV to ensure that they reflect current industry thinking and are compliant to cGMP, client’s corporate policies & quality standards manual and regulatory guidelines
• Perform periodic reviews of computer systems
• Assist in the implementation of the site Data Integrity programme
• Perform remediation of computer systems
• CSV Lead for new projects (this includes LabX, Laboratory Monitoring System, building management system, Serialisation, facility monitoring system, various manufacturing and lab systems)
• Generation of computer validation documents (e.g. Val Plan, Functional Design Specification, IQ, OQ, ERES, DRP)
• Co-ordination of CSV related activities
• Ensure the client’s Computer System Site Inventory is periodically reviewed and kept current.
• Conduct periodic internal-audits to the implementation
• Represent the computer systems validation approach to regulatory authorities during inspection.

Requirements

• Minimum of degree in a relevant discipline.
• 10 years’ experience of CSV in a pharmaceutical manufacturing environment. (with a minimum of 5 years in a lead CSV role)
• Extensive experience working with manufacturing system (i.e. PLC/SCADA), Lab systems and business information system
• Experience in preparation and presenting information during FDA/MHRA
• Excellent understanding of the regulatory expectations relating to CSV.
• A broad understanding of validation principles in general and the GMP expectations as applicable.
• In depth knowledge of GAMP
• An understanding of Data Integrity in line with recent regulatory expectations.
• Proven ability to plan resources and manage priorities to consistently deliver on time against tight project timelines.
• Well-developed communication skills with the ability to persuade and influence all levels of colleagues, regulators and industry specialists.
• Good Understanding of Aggregation and Serialisation
• Good communication skills and the ability to train people in CSV

Interested candidates should submit an updated CV.
Please click the link below to apply, call Veronica on +44 20 3966 9800 or alternatively send an up to date CV to veronica.perez@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***