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.
Key responsibilities:
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)
Must-have competences:
Former experience from a similar Validation SME role
Strong Validation experience
Experience with compliance and with QMS
Understand agile delivery model
System maintenance experience
Nice-to-have competences:
Hands on experience in the ALM testing tool will be an added advantage.
Former experience with Veeva products
Pharmaceutical experience
Start : 1st August
Duration : 11 months
Allocation : Fulltime, time & material
Location : Søborg (hybrid 3 days onsite & 2 days remote)
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