Senior QA Validation Specialist

Responsibilities

• Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analysing the results of testing and determines the acceptability of results against pre-determined criteria
• Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviewing, editing and approval deviation notifications, deviation investigations, and corrective actions
• Reviewing and approval of change controls, SOPs, reports and other documentation
• Coordinating with other departments or outside contractors/vendors to complete validation tasks
• Managing projects and prepares status reports
• Providing oversight to contingent workers may be a requirement
• The environment and physical rhythms of this role:
• Ability to work independently or as part of a team
• Ability to communicate with transparency
• Demonstrate respectful behaviour at all times
• Gathers and organises information
• Meets commitments on scope and on time
• Follows directions, performs well-defined tasks
• Effective time management skills
• Seeks to identify continuous improvement needs
• Let's find out if we're a fit:
• To be considered for this opportunity you must have a BS/BA in Engineering, Chemistry or Life Science and requires at least 5 - 8+ years' proven experience in Commissioning / Qualification experience with Large Scale Process equipment
• Thrive today. Grow tomorrow.
• #IRELIM #JOBSIEST #LI-Onsite #REGNIEQA
• Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
• For jobs in Canada: this posting is for an existing position.
• Salary Range (annually)
• €54,200.00 - €88,400.00

Benefits

Additional Information

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Senior QA Validation Specialist to join our Quality Assurance team. This position offers the opportunity to contribute to a fast-growing, science-driven organisation making a meaningful difference to patients worldwide. When & where: Location: Raheen, Limerick Some travel may be required.

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