Summary
This role will support Quality Assurance and Regulatory Affairs activities, ensuring compliance with cGMP/cGxP requirements. Responsibilities include maintaining the Quality Management System (QMS), supporting product release, managing quality investigations, document control, and regulatory submissions.
Key Responsibilities
Ensure compliance with cGMP, cGxP, and Health & Safety regulations.Manage quality systems including deviations, CAPA, change control, complaints, and document control.Support non-conformance investigations and finished product release.Maintain SOPs, records, and quality documentation.Prepare and manage regulatory submissions and product labelling (NDC, UPC, SPL).Ensure product registrations are maintained with relevant regulatory authorities.Review and approve product labelling and packaging documentation.Monitor KPIs and support continuous improvement initiat...