Job Description
QARA Specialist
Reporting to the EMEA QA/RA Manager, in this role your main functions will be to maintain and develop the local quality and pharmacovigilance management system, support the product registration with local competent authorities, undertake relevant training to deputise for Responsible Person (RP) and manage various projects.
Role responsibilities
1. Responsible for the regulatory compliance of the site according to UK and Ireland regulations for Pharma and Medical Device distribution
2. Preparation and/or coordination of data and analytics for the monthly Product Surveillance Committee
3. Documentation review for the batch release of Pharmaceutical manufactured products
4. Supporting the supply of regulatory information to international divisions and external parties
5. Preparation and presentation of pharmacovigilance reports
6. Maintain an effective ISO 13485 certified Quality Management System (QMS) that enhances the customer facing value of the organisation and reduces business risk, ensuring that processes needed for the QMS are documented.
7. Execution of audits of dealers against the annual audit plan, management of CAPAs and escalation of any critical deficiencies as deemed necessary
8. Maintain good documentation practice and manage the UKD Document Control infrastructure (including, but not limited to activities as...