Engineering & Electronics
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.
- 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.
- 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 firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***