Senior Advisory Consultant

3 weeks ago

Ruddington, Nottinghamshire, United Kingdom Ideagen Full time

Job Summary

Ideagen is seeking a highly skilled Senior Advisory Consultant to lead CSV projects on behalf of customers in alignment with GxP expectations and customer requirements.

The ideal candidate will have at least 3-5 years of experience with computer system validation, a degree in a science/health-related or IT-related subject, and fluency in written and spoken English.

Key Responsibilities

  • Manage and coordinate formal testing of computerised systems, including planning and writing of test cases, coordination of resources, execution of testing, completion, and approval of documentation.
  • Follow Good Documentation Practises and adhere to Data Integrity requirements for completion of all documentation.
  • Complete any allocated training (internal and customer requested) on time and in full.
  • Investigate and troubleshoot any potential software issues/bugs.
  • Communicate any software bugs or required updates as appropriate to software developers/vendors for appropriate resolution.
  • Review computerised systems used in GxP processes to determine impact and develop a risk-based approach to meet global regulatory and customer requirements.
  • Review CSV documentation to ensure data integrity expectations are maintained.
  • Ensure project timelines are met to support customer commitments.
  • Escalate any issues in a timely manner to ensure appropriate resolution.
  • Perform and report 3rd Party audits on behalf of customers.
  • Proactively highlight any areas for process improvement and actively contribute and participate in any internal continuous improvement initiative.

Requirements

  • At least 3-5 years of experience with computer system validation.
  • Degree in a science/health-related or IT-related subject or equivalent experience.
  • Fluency in written and spoken English.
  • A knowledge and understanding of a wide range of different types of systems used within the life sciences including MES, QMS, ERP, LIMs, SAS, SAP, etc.
  • A knowledge and understanding of the requirements related to 21 CFR Part 11, EU Annexe 11, Data Integrity, and GAMP.
  • Experience in handling regulatory inspections and audits is an advantage.
  • Computer literacy, including proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint).

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