Validation SME

at  Skillspark AB

START31-07-2024

DURATION4-6 months
emagine is seeking an experienced Validation SME for our client in the pharmaceutical industry.
Our client is looking for a Validation SME to join their Agile teams in ART.
The consultant will be responsible for testing functionality build by the developers and business, ensuring this is ready for deployment.

• Responsible for keeping the systems in compliance with the QMS. Ensure a close working relationship with the QA team and other relevant stakeholders to fulfill the overall quality assurance responsibility.
• Support Computer Systems Validation related work and validation lifecycle, like system requirements, testing and traceability towards completion of validation work.
• Participate in system operation and maintenance to secure robust IT System Management.
• Support system releases while performing as Validation responsible supporting system releases by preparing validation documents like Implementation Plan, Verification Plans and Reports
• Understanding of AGILE delivery model and working in AGILE teams will be an added advantage
• Acts as liaison between Quality Assurance and the system management to assure that the GxP system meets the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines.
• Ensuring the quality and acceptance of all validation deliverables before the approval to Go-live during Release closing window.
• Handling change requests
• Authoring, Review & sign off for the Validation deliverables
• Participate in Annual Periodic reviews (user review report, configuration review report, IT periodic system evaluation)