Conduct validation of custom build and COTS applications
Act as guardian of the computer validation process and work across multiple product teams, performing validation activities as per SDLC
Oversee official validation execution runs where test automation is not available
Conduct validation test activities where required
For COTS applications, perform full validation cycles including review of test cases and evidence of execution runs
Prepare Validation package, including Validation Plan and Validation Report documents and review other validation documents prepared by development teams
Ensure a full audit trail exists for each validated system
Look for improvements in the validation process to streamline with rapid delivery cycle
Track and manage resolution of bugs or issues generated during validation
Serve as the quality gateway for own deliverables; anticipate problems and mitigate impact
Represent the company during customer audits relating to computer systems
Work independently and collaboratively in a fast-paced, matrixed environment and liaise with Quality Management, Product Management, Engineering, DevOps and IT Operations
Requirements
Previous experience within the medical device industry in Quality/Engineering
Knowledge of Computer System Validation including GAMP 5, 21 CFR Part 11 and CGMP requirements
An ability to effectively communicate ideas to your team-mates and can work as part of a team, regardless of their seniority level
Flexible, highly motivated individual and accountable
Third level degree but experience and proven track record of 1+ years in testing or validation of computer systems counts
A history of having close attention to detail with a high degree of accuracy
Experience with or an interest in modern web and mobile technologies
Being open to change, new ways for approaching problems and breaking what works before making it
Willingness to travel internationally as required
Eligible applicants must already hold valid and legal work permit for Ireland (no sponsorship available)
Benefits
25 days holidays
Length of Service Awarded Holiday Days
Pension
Healthcare
Life Insurance
50% Maternity leave pay after capped length of service
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