Computer System Quality Specialist

☞ Asset Recruitment Ltd

View: 104

Update day: 07-05-2024

Location: Louth East Midlands

Category: IT - Software

Industry: Mechanical or Industrial Engineering Biotechnology Pharmaceuticals

Position: Entry level

Job type: Full-time

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Job content

Job Summary

Based within the QA department the Computerised System Quality Specialist will act as the Computer Systems Quality representative in support of Computerised System Validation (CSV) activities executed on site. The Computerised System Quality Specialist will be responsible for ensuring the timely review/approval of documentation, closure of all executed documentation and resolution of any internal/external quality issues relating to CQV project activities in accordance with Project and Site SOPs, as applicable. The role requires thorough understanding and experience of the validation requirements associated within a GMP manufacturing facility in order to provide quality oversight and guidance.

Essential Duties And Responsibilities
  • Quality review and approval of Computer System Validation (CSV) and IT compliance documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
  • Ensure that all systems, conform to relevant regulatory requirements, company specifications and standards as well as industry best practice.
  • Review and approve computerised system validation documentation, including; URS, FDS, Test Protocols/Reports, SOPs etc.
  • Participate in software, equipment and instrument qualification where necessary.
  • Participate in event/deviation investigation and change evaluation during qualification, to ensure the systems, software and equipment meet quality and compliance requirements prior to release.
  • Responsible for ensuring that all manufacturing processes, QC and Enterprise systems perform and operate as per their design.
  • Work with all personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.

Requirements
  • Bachelor’s Degree in Engineering, Science or other relevant Technical disciplines
  • Minimum 3 years’ experience in a similar role
  • Strong experience in a Quality Engineering/Quality Assurance role for Biologics, medical device or pharmaceutical manufacturing.
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices
  • Good understanding of the principles of Computerised System Validation.
  • Ability to operate across functional boundaries, both internal and external
  • Demonstrated knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO)
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Deadline: 21-06-2024

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