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
Responsible for the regulatory compliance of the site according to UK and Ireland regulations for Pharma and Medical Device distribution Preparation and/or coordination of data and analytics for the monthly Product Surveillance Committee Documentation review for the batch release of Pharmaceutical manufactured products Supporting the supply of regulatory information to international divisions and external parties Preparation and presentation of pharmacovigilance reports 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.
Execution of audits of dealers against the annual audit plan, management of CAPAs and escalation of any critical deficiencies as deemed necessary Maintain good documentation practice and manage the UKD Document Control infrastructure (including, but not limited to activities associated with CAPAs, Change Controls, Nonconformance) Maintain knowledge of any changes in Medical Device and Pharmaceutical regulations and the potential impact on the UKD manufacturing and distributing activities.
Examples include EU MDR, MDD, Brexit, GxP, environmental requirements Communicate with clarity and succinctness the nature of the change, impact on the business, and options that can be considered to remediate and/ or mitigate the impact of any potential change Support product registrations with local competent authorities Support Health Authority/ Notified Body inspections on investigational sites or external service providers.
Also support with the drafting of any responses and execution of any post inspection activity Conduct any other QARA related activities in line with the Quality Plan as defined by the EMEA QARA Manager Escalate urgent and critical matters to EMEA QARA Manager where necessary.
Profile requested
Educated to Degree level, preferable in a science, engineering or medical discipline desirable Some experience within highly regulated environment (e.g.
ISO 13485, GDMP) Preferable internal audit experience Strong customer service and interpersonal skills High degree of accuracy and attention to detail Project management desirable As part of our team, you'll experience the spirit of an international and innovative market leader in the dental industry.
Besides an attractive remuneration package, you will also be eligible for a variety of employee benefits, such as:
26 days' annual leave, an attractive company pension scheme and a flexible benefit scheme ( including health insurance, dental cover, medical cash plan...).
We attach great importance to your development: a comprehensive induction, further training opportunities and access to LinkedIn Learning are available to you.
Take advantage of personal and professional development opportunities through our worldwide mentoring and coaching program.
In addition, we offer an extensive, global employee assistance program that provides a wide range of benefits as well as retirement benefits.