Senior Quality Assurance Professional
5 days ago
Job Title: Senior Quality Assurance Professional
About UsWe are a leading pharmaceutical company dedicated to discovering and delivering innovative medicines that solve serious health issues. Our mission is to have a remarkable impact on people's lives across various therapeutic areas.
Job DescriptionThe Commercial Quality Specialist will provide independent support in the affiliate, ensuring quality system requirements are met for pharmaceutical products, medical devices, combination products, biologics, and cosmetics. This role involves storage and distribution, quality events, supplier controls, product quality review, risk management, agency inspections, and overall quality manual requirements.
- This position requires an in-depth knowledge of one or more elements and is considered a subject matter expert in these areas.
- You will ensure all product, process, or system-related quality activities supporting the business at the affiliate are in compliance with corporate, governmental, and local regulations.
You will work closely with cross-functional teams to design effective quality systems, procedures, and processes within our organization. Your responsibilities will also include assessing compliance to processes, procedures, and regulations to identify potential gaps and implement improvements.
- You will plan, prepare, review, and approve quality documentation such as change controls, product reviews, and other local requirements.
- You will support internal, external, and MoH audits as directed by the manager and lead self-inspections.
- You will coordinate and investigate quality events such as deviations, non-conformances, and corresponding action plans including decisions.
This role requires strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault. You should have a full understanding of local GxP requirements, including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics.
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