Senior Quality Assurance Specialist
5 days ago
The Commercial Quality Specialist is responsible for providing quality support in the affiliate. Key areas of focus include quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and cosmetics.
Responsibilities:- Responsible for integrating local quality regulations for drugs, biologics, device and/or combination products, and cosmetics.
- Design effective quality systems, procedures, and processes to ensure compliance and efficiency throughout our quality systems.
- Work on assessments to determine compliance to processes, procedures, and regulations to identify potential gaps and mitigate improvements.
- Plan, prepare, review, and approve quality documentation such as change controls, product reviews, and other local requirements.
- Support internal, external, and MoH audits as directed by the manager, lead self-inspections.
- Coordinate and investigate quality events such as deviations, non-conformances, and corresponding action plans including decisions.
- Execute supplier qualification program including performance monitoring for key suppliers.
- Monitor metrics and KPIs to ensure compliance.
- Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
- Support the Management Review process for the affiliate.
Represent Commercial Quality in cross-functional teams, projects, and programs, as assigned by management.
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Senior Quality Assurance Specialist
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