CSV Lead

Proclinical are recruiting a CSV Lead for a pharmaceutical establishment. This role is on a contract basis. The client is focused on bettering people's health and lives.

Responsibilities:

• May have the potential to be extended - Types of projects coming up new pre-fill syringe facility, heavily automated - filling and packaging lines.
• Uphold, develop, execute and monitor site policy and procedures for CSV to guarantee that they imitate current industry thinking and are compliant to cGMP, client corporate policies & quality standards manual and regulatory guidelines.
• Conduct periodic reviews of computer systems.
• Support the execution of the site Data Integrity programme.
• You will perform remediation of computer systems.
• Handle the responsibilities of a CSV lead for new projects (this includes LabX, Laboratory Monitoring System, building management system, Serialisation, facility monitoring system, numerous manufacturing and lab systems).
• Manage generation of computer validation documents (e.g. Val Plan, Functional Design Specification, IQ, OQ, ERES, DRP).
• Organisation of CSV related activities.
• Guarantee the client Runcorn Computer System Site Inventory is intermittently reviewed and kept current.
• Deal with periodic internal audits to the application.
• Represent the computer systems validation method to regulatory authorities during inspection.
• Timely support for the CSV of multiple site projects.
• Regulatory guidelines / expectations.
• Planning, Organising and Controlling.
• Provide assistance for multiple projects and periodic reviews with concurrent timelines.
• Point of contact with Others.
• Decision Making Authority.
• Handle risk management based on policy and guidance documents, leading to direction and content of validation deliverables.
• Prioritisation of CSV activities.

Skills & Requirements:

• Educated to a degree level within a suitable topic.
• Wide-ranging experience of CSV in a pharmaceutical manufacturing setting. (at least 5 years in a lead CSV role).
• Operated with manufacturing system (i.e. PLC/SCADA), Lab systems and business information system.
• Expert knowledge of CSV resulting through both practical experience and theoretical studies.
• Exceptional understanding of the regulatory expectations relating to CSV.
• A comprehensive understanding of validation principles in general and the GMP outlooks as pertinent.
• Thorough knowledge of GAMP.
• Solid understanding of Data Integrity in line with recent regulatory expectations.
• Demonstrated ability to plan resources and handle priorities to dependably deliver on time against tight project timelines.
• Sharp communication skills with the aptitude to sway and inspire all levels of colleagues, regulators and industry specialists.
• Former experience in planning and displaying information during FDA/MHRA inspections.

If you are having difficulty in applying or if you have any questions, please contact Saulge Hubert at +44 203 949 8594.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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