Computer System Validation Specialist – Medium to Small Projects

Salary: £78 per hour

Summary

• Generation and review of all lifecycle validation documentation for the qualification of equipment and software
• Execution of validation activities in protocols and test scripts
• Completion of periodic reviews for existing systems
• Adherence to internal procedures for quality and validation, and external cGMP and Regulatory guidelines
• Maintain Status Sheets / Registers for status of work completed
• Provision of data to support CSV questions at customer audits and regulatory inspections

Qualifications

• BSc or equivalent in science or engineering subject
• Validation and Compliance qualification (desirable)

Experience

• Extensive experience in
  
  • CSV and Data Integrity within the biopharmaceutical industry including manufacturing and laboratory systems
  • Pharmaceutical Quality Systems
  • Sound knowledge of GMP, ER/ES, GAMP, Eudralex / Orange Guide Annex 11, Title 21CFR Part 11, Data Integrity
  • Working with moderate supervision

Index Recruitment Ltd is acting as an Employment Business in relation to this vacancy.

“Due to the high volume of applications, we currently receive, we are unable to respond to all candidates. If you do not hear from a Consultant within 5 working days unfortunately you have been unsuccessful on this occasion”