Quality/ Regulatory, PV co-ordinator

• Feb 2023 - Present

• Review and implement processes and procedures in accordance with GDPR legislation, ISO27001, ISO14001, and FDA, European and other regulatory requirements. • Manage administrative tasks within the quality function and provide administrative support to the Regulatory Affairs Manager. • Be involved in the implementation of an electronic Quality Management System (eQMS) in HB. • Support the ongoing management of the eQMS. • Track and trend quality issues/complaints related to HB devices. • Assist with document control to ensure documentation is current and accessible. • Report deviations and investigate, implementing effective corrective and preventive actions (CAPA). • Document, investigate, and report quality complaints, taking necessary actions. • Track, monitor, and report on all change management activities. • Conduct and document internal process audits, including call monitoring. • Develop annual training plans for all company departments. • Design and develop training programs, both outsourced and in-house, in collaboration with department managers. • Conduct organization-wide training needs assessments to identify knowledge or skill gaps. • Be involved in PV reconciliations, PV training, and provide guidance on AE reporting, MDR reporting. • Analyze SDEAs and manage PV agreements, BAA, MSA. • Actively participate in the quality operations for pregnancy risk management platforms like Pathfinder and patient safety hub. • Actively participate in the validation testing of the company's QMS and systems like Zendesk. • Be a main point of contact for PV management. • Coordinate internal and external audits, including ISO 27001 and SOC 2 audits. • Actively manage non-conformities and support supplier evaluation processes. • Collaborate with team members to ensure effective quality management. • Conduct training sessions on using the QMS,GDPR,PV and CAPA management. Show less

Research Assistant

• Sep 2021 - Sep 2022

▪ Demonstrated comprehensive knowledge of various regulatory bodies FDA (Food and Drug Administration), MHRA (Medicines and Health Products Regulatory Agency). ▪ Established knowledge of Good Manufacturing Practice (GMP, GLP, GCP, GDP, cGMP) regulations, ICH Quality by design, Risk Management, Validation Strategies, Auditing, and Inspection. ▪ Learned about the upstream and downstream processing, production and quality systems, theoretical operation of bioreactors and autoclaves, technology transfer, strategy, leadership & the culture of innovation, lean principles, operational excellence & the science of innovation, and clinical research management in the pharmaceutical industry. Show less

Quality Assurance Specialist

• May 2020 - Aug 2021

• Track and analyze quality issues and customer complaints related to healthcare devices. • Assist with document control, ensuring accurate and up-to-date documentation. • Report deviations and actively participate in the investigation and implementation of Corrective and Preventive Actions (CAPA). • Document, investigate, and report quality complaints and feedback from customers and internal sources. • Monitor and report on change management activities to ensure compliance with quality standards. • Assist in coordinating and participating in internal and external audits. • Continuously monitor and audit product processes and procedures to guarantee adherence to stringent quality standards and compliance requirements. • Collaborate closely with team members to address and resolve quality-related challenges, fostering a culture of quality within the organization. Show less

Pharmacovigilance Associate

• May 2019 - Apr 2020

• Conducted safety reports on drugs and other treatments. • Wrote and reviewed drug safety reports, case report forms, serious adverse event • reports and forms. • Report writing based on case reports and daily activities. • Conducted in-depth interviews with patients. • Documented and communicated problems with an appropriate action plan. • Notified about the early warning signs of the adverse effects of drugs. • Attended team meetings and provided training to other departments. • Attended training scheduled for overall learning improvement. Show less

Pharmacy Intern

• Jul 2017 - Aug 2017

Pharmacy Assistant

• Nov 2013 - Mar 2017