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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
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