In this role, you will maintain relationships with stakeholders and customer where disruption is caused by essential maintenance and construction work, ensuring that complaints service and applications for mitigating circumstances are co-ordinated.
Drive the process of responding to audit/inspection findings and develop appropriate capas for internal processes within argos, external suppliers/service providers and inspections by external regulatory agencies (e.G. Fda, ema, etc.).
Work with members of mv, r&d, qc, qa and other groups (manufacturing, validation, etc.) as necessary to generate validation and stability protocols for raw materials, process intermediates, and final product.
In this role, the selected candidate will plan and conduct Quality Assurance and Contamination Prevention audits at third party contract manufacturing sites and bulk distribution terminals to ensure compliance with guidelines.
The Quality Specialist IV has responsibility for GMP activities related to materials, production, product release, labeling, change control and post market monitoring activities for assigned RAI operating company. This individual will serve as the main quality contact between Contract Manufacturing Organizations (CMOs) and S&RA Quality Assurance group.