Commercial Quality Assurance Specialist
1 week ago
The Commercial Quality Specialist is a critical position within our organization, responsible for providing independent quality support in the affiliate. This role plays a key part in ensuring all product, process, or system-related quality activities supporting the business at the affiliate from receipt of final product through distribution are compliant with Corporate, governmental, and local regulations.
Key Responsibilities:- Quality System Requirements: Ensure quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and cosmetics are met, adhering to regulatory standards.
- Storage and Distribution: Support storage and distribution processes to guarantee product integrity and prevent any deviations from quality expectations.
- Supplier Controls: Execute supplier qualification programs and performance monitoring for key suppliers, ensuring they meet our quality standards.
- Product Quality Review: Conduct regular product quality reviews to identify potential issues and take corrective actions.
- Risk Management: Identify and mitigate risks associated with product quality, minimizing any impact on our business.
- Audit Preparation: Prepare for internal and external audits, including agency inspections and self-inspections, to ensure we are always ready.
- CAPA: Investigate and resolve quality events, deviations, and non-conformances in a timely and effective manner.
- Quality Manual: Ensure all quality manual requirements are met and up-to-date, reflecting our commitment to quality excellence.
- Bachelor's Degree: In Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred.
- Experience: 3+ years in quality assurance, GMP or GDP environment preferred, with a strong track record of delivering quality results.
- Computer Skills: Familiarity with SAP, Track Wise, Compliance Wire, and One Vault required, with the ability to quickly learn new systems.
- Knowledge: Full understanding of local GxP requirements, including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics.
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