Romina Briffa, Phd Email & Phone Number

Cambridge, Cambridgeshire, Gb

Msida, N/A, Mt

St Andrews, Fife, Gb

Marsa, Mt

Reporting directly to the Executive Director for the Healthcare Division, I contribute to the development and implementation of regulatory and quality strategies for new projects. I also liaise with Regulatory Affairs/Quality and other functional areas including external partners and consultants in the planning, organisation, and preparation of regulatory documents for submission to governmental regulatory agencies and subsequent progress towards fulfilment of regulatory and quality commitments. I author and/or review standard operating procedures (SOPs) and ensure SOPs are compliant with current regulatory and quality requirements. Moreover, our unit is responsible for pharmacovigilance and compliance. I coordinate and am responsible for preparation and coordination of supplier audits and authority inspections (Good Distribution Practice (GDP), Regulatory Affairs, and Pharmacovigilance) and also review Quality and Safety Data Exchange Agreements with all our suppliers. I am accountable for managing the quality management system of the Healthcare Division System, including the training and supervision of the pharmaceutical stores and to ensure that all the activities are GDP compliant. Key activities covered are: Organization and Management ResponsibilitiesPersonnel and trainingDocumentation ManagementComplaints HandlingAlert and Recall ManagementDeviations handlingInternal AuditPreparation for InspectionsVendor Management/OutsourcingContinuous Improvement (Corrective and preventive actions)Change ManagementOur unit is responsible for maintaining a documentation system and assuring that all procedures are in line with the procedures and regularly updated. Furthermore, I coordinate validation activities of various components of the system.

Marsa, Mt

Phd, Molecular And Clinical Medicine

Master Of Science (Ms), Pharmacy

B. Pharm. (Hons.)