QA Specialist

• Quality oversight of and guidance on capital projects
• Maintenance of all aspects of GMP compliance for the area(s) of responsibility
• Establishment, maintenance and management of a control system for the specific Quality System(s)/Program
• Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program
• Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program -
• Review and approval of change controls and failure investigations, associated with the area(s) of responsibility
• Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
• Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, GMP utilities and periodic quality evaluations.
• Review and approval of other key GMP documents such as GMP standard operating procedures, specifications, process flow diagrams as appropriate to area of responsibility
• Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in area of responsibility - Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility

• 5+ years experince in similar position
• May hold BSc, MSc, in Chemistry, Engineering or related discipline

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