CSV Lead

Job content

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 (phone number removed) 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***

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert