Primary Responsibilities Of This Position Are

• Receipt, testing and disposition of incoming materials/products for use in Production or Distribution
• Creation and review of materials/product specifications
• Issue and archive documentation pertaining to incoming/dispatch material/product records, test records and specifications
• Support the assessment of returned materials/products and the required documentation for disposition
• Update inventory management system for dispositioned materials/products and products intended for destruction
• Perform Pre-Dispatch inspection in warehouse according to PCI procedures to ensure products have been correctly picked, prepared and shipped according to Client/Sponsor orders.
• Conduct product inspection in different storage condition warehouses e.g. Ambient, 2-8°C and -20°C conditions.
• Support the ongoing management of retention samples
• Review Warehouse documentation and logs to ensure compliance with Good Documentation Practices
• Complete, review and support site investigations/escalations for the determination of root cause/impact/risk for EVENTs, Deviations, Complaints, Non-Conformance and change controls.
• Support the completion of internal, client and regulatory inspections, including the response to findings and completion of corrective and preventative actions
• Support applications and management of import / export permits
• Create and review operational SOPs/WI/Forms (as required)
• Support mock recall and recall activities instigated by PCI or clients
• Action continuous improvements to enhance Quality Operations performance, compliance to regulatory requirements and improvements in site Standard Operating Procedures (SOPs)
• Report metrics related to Incoming Release and assist with the preparation of Quality Management Review information
• Support the completion of other Quality Operations team responsibilities as required (e.g., Product/Material Inspections, product specification file creation etc)
• Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.
• Escalate quality issues to the Quality Control Associate Manager and Quality Operations Manager
• Other activities as directed by the Quality Control Associate Manager and Quality Operations Manager
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Qualifications & Experience Required

• Bachelor of Science or related discipline
• Experience in a Quality role in cGMP pharmaceutical environment
• Proficient user of Microsoft Word and Excel
• Use of quality management system and inventory management system software in a regulated industry
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