Tracey Goldsworthy
Responsible Person Consultant (Rp Pcqi) @Global Regulatory Services Ltd
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WORK HISTORY
Responsible Person Consultant (Rp Pcqi) @Global Regulatory Services Ltd
Existing and new Regulations are explained to clients and ensure Regulations are adapted to the client’s processes. ISO 9001:2015, ISO 13485:2016• GDP-related activities of clients ensuring GDP compliance. • Responsible Person Consultant and named on WDA license, responsible for filing variations. Duties include Bona fide checks, ensuring Quality system is implemented and maintained, release returned products to saleable stock, approving SOP’s,• Arrange meetings with clients• Communicating with UK and EU Regulatory Authorities• GDP Training Officer • GCP/GDP Audits• Implementation of procedures and continuously improving workflow for new clients• Special Projects• Cosmetic Regulations• Responsible Person and RPi consultant duties include Bona fide checks, ensuring Quality system is implemented and maintained, deciding on the final disposition of returned, rejected, recalled or falsified products, approving any returns to saleable stock approve SOP’s, demonstrate GDP compliance, focus on accuracy of records, ensuring that initial and continuous training programs are implemented and maintained, coordinating and promptly performing any recall operations for medicinal products; ensuring that relevant customer complaints are dealt with effectively, ensuring that suppliers and customers are approved, approving any subcontracted activities which may impact on GDP, ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place, keeping appropriate records of any delegated duties, ensuring that any additional requirements imposed on certain products by national law are adhered to• Manage CAPAs, Deviations, Change Controls, and complaints where named as RP on the WDA
EDUCATION
University of South Africa/Universiteit van Suid-Afrika
Bachelor of Laws (LLB)
SKILLS
ABOUT TRACEY GOLDSWORTHY
Responsible Person Consultant (RP/RPi/PCQI)
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