Specialist, Quality Operations

Job Description Summary

Job Description

Key Requirements:

• DeliverQuality Operations and Quality Compliance activities in line with GxP, regulatory requirements, internal quality standards and SOPs.
• Manage and supportquality documentation, including SOPs, working procedures, process maps, trend reports, qualification reports and technical investigations.
• Supportdeviations, quality events, investigations and CAPA management, including tracking, trending and timely closure.
• Supportinternal/external audits, inspections, self-inspections and supplier audit activities.
• Manage quality-related activities acrossAPQR, QAA, QRA, KQI metrics and Approved Supplier Lists.
• Supportvendor/supplier quality management, including supplier onboarding, assessments, agreements and monitoring.
• Generate and analyzequality metrics and reports using approved systems/tools and ensure accurate, timely deliverables.
• Maintain quality records, trackers, SharePoint content and relevant documentation.
• Partner effectively with internal stakeholders, customers and business partners while supporting continuous process improvement.

Essential Requirements:

• Good understanding ofGxP, Quality Operations and Quality Compliance requirements.
• Experience 5-7 years.
• Hands-on experience withdeviations/quality events, investigations and CAPA.
• Experience creating/reviewingSOPs and other GxP/quality documentation.
• Experience supportingaudits, inspections and compliance activities.
• Ability to work withquality systems/tools, generate reports and track quality metrics.
• Strong attention toaccuracy, compliance, ownership and timely delivery.
• Ability to effectively communicate and collaborate withcross-functional stakeholders and business partners.

Desirable Requirements:

• Experience withAPQR, QAA, QRA, KQI reporting and Self-Inspection planning.
• Exposure tosupplier/vendor quality management, supplier audits and Approved Supplier Lists.
• Experience with1QEM / Quality Event Management and Quality Analytics tools.
• Exposure toGMP external audits, Health Authority inspections and supply-chain quality.
• Experience managingSharePoint, quality repositories, trackers and document archival.
• Exposure toQuality Management Review metrics/reporting and continuous improvement initiatives.

Skills Desired