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Commercial Quality Specialist
3 mesi fa
Manpower is seeking a Commercial Quality Specialist for a multinational pharmaceutical company.
In this role you will be responsible for ensuring compliance and efficiency across affiliate's quality activities related to pharmaceutical products, medical devices, combination products, and biologics. This includes areas such as Storage and Distribution, quality events/product shortages, Supplier Controls, Product Quality Review, Risk Management, inspections/audits, CAPA, and overall Quality Manual requirements.
Job Core Responsibilities
Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement 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.
Represent Commercial Quality in cross functional teams, projects and programs, as assigned by management.
Preferred Knowledge and Experience
Bachelor's Degree in a technical/scientific field;
3+ years experience in quality assurance, GMP or GDP environment;
Proficiency in computer skills (SAP, TrackWise, ComplianceWire, and OneVault)
Full understanding of local GxPrequirements and regulations.
Bachelor's Degree in a technical/scientific field;
3+ years experience in quality assurance, GMP or GDP environment;
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