Senior Quality Assurance Specialist
2 days ago
The Commercial Quality Specialist plays a pivotal role in ensuring the affiliate's quality systems meet corporate, governmental, and local regulations. Key responsibilities include designing effective quality systems, procedures, and processes to guarantee compliance and efficiency throughout our quality management systems.
- Integration of local quality regulations for drugs, biologics, devices, and/or combination products and cosmetics is crucial.
- Development of quality documentation, such as change controls, product reviews, and other local requirements, requires meticulous planning and preparation.
- Supporting internal, external, and MoH audits, leading self-inspections, and coordinating quality events like deviations and non-conformances are essential tasks.
- Skillful execution of supplier qualification programs, including performance monitoring, is vital to ensure quality standards are met.
- Monitoring metrics and KPIs to guarantee compliance with Good Storage and Distribution Practices is also necessary.
To excel in this position, candidates should possess a Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or a related technical/scientific field. A minimum of 3 years of experience in quality assurance, GMP, or GDP environments is highly desirable.
Candidates must demonstrate strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault, as well as a deep understanding of local GxP requirements, regulations, and standards affecting devices, biologics, pharmaceutical products, and cosmetics.
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