Quality Assurance

Quality Assurance

West Dublin

Salary DOE

Role Requirements:

• Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
• Quality review and approval of Validation documentation and SOPs to support site validation activities:
• Review of DS & QRAES documents
• Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
• Review of executed validation documents and reports
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
• Perform all activities in compliance with company safety standards and SOPs

Candidate Requirements:

• Bachelor’s degree in Engineering or Life Science related discipline.
• 2+ years of Quality Assurance experience in a Life Sciences environment.
• Manage internal ISO quality process.
• Understanding of principles of Validation and New Product Introduction
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Proven experience participating in or leading audits and inspections.

INDCAT1