Specialist, Quality Operations
Job Description Summary
• Deliver Quality Operations and Quality Compliance
activities in line with GxP, regulatory requirements, internal quality standards and SOPs.
- Manage and support
quality documentation
, including SOPs, working procedures, process maps, trend reports, qualification reports and technical investigations.
- Support
deviations, quality events, investigations and CAPA management
, including tracking, trending and timely closure.
- Support
internal/external audits, inspections, self-inspections and supplier audit activities
.
- Manage quality-related activities across
APQR, QAA, QRA, KQI metrics and Approved Supplier Lists
.
- Support
vendor/supplier quality management
, including supplier onboarding, assessments, agreements and monitoring.
- Generate and analyze
quality 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.
• Good understanding of GxP, Quality Operations and Quality Compliance
requirements.
- Experience 5-7 years.
- Hands-on experience with
deviations/quality events, investigations and CAPA
.
- Experience creating/reviewing
SOPs and other GxP/quality documentation
.
- Experience supporting
audits, inspections and compliance activities
.
- Ability to work with
quality systems/tools
, generate reports and track quality metrics.
- Strong attention to
accuracy, compliance, ownership and timely delivery
.
- Ability to effectively communicate and collaborate with
cross-functional stakeholders and business partners
• Experience with APQR, QAA, QRA, KQI reporting and Self-Inspection planning
.
- Exposure to
supplier/vendor quality management
, supplier audits and Approved Supplier Lists.
- Experience with
1QEM / Quality Event Management and Quality Analytics tools
.
- Exposure to
GMP external audits, Health Authority inspections and supply-chain quality
.
- Experience managing
SharePoint, quality repositories, trackers and document archival
.
- Exposure to
Quality Management Review metrics/reporting
Not included in the source posting: about the role, what you'll do, benefits.
Skills
Who can apply
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