On behalf of our client, a healthcare and medical devices company, we are currently recruiting for a Quality Specialist.
The office is based in Dublin and this is a hybrid role with 2 days per week in the office.
This is an exciting and rare opportunity if you are looking for a rewarding career and personnel development within an experienced team.
You will be challenged in this role as we adapt to the changing needs of the healthcare sector in Ireland.
It is a unique opportunity to work within a dynamic and collaborative organisation with exposure to cooperate on projects with our international colleagues.
This role is full of variety and gives great job satisfaction as you will be part of improving patient outcomes.
In this role your core responsibilities will include but not limited to: Support the Quality Manager/ Responsible Person and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) for Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.
Assist the Quality Manager/Responsible Person and Qualified Person in the development of continuous improvement and compliance projects within the Quality Department.
Assist in the completion of internal audits of GMP/GDP systems, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken.
Ensuring the GMP and GDP elements of the Quality Management system (QMS) is understood by providing training to company personnel regarding updated documents.
Recording, investigating and reporting incidents and deviations to the Quality Manager and Qualified Person Assisting Process Owners in assessing risks and assigning counteractive measures.
Management of the stability data for the support of the expiry dates Co-ordinate customer and supplier complaints - including investigations, reporting, and trending Assist in the co-ordination and documentation of product recalls and mock recalls.
Knowledge of EU quality related pharmaceutical regulations Experience of a MIA environment Experience in dealing with 3rdparty warehouse distribution models.
Ideally a minimum of 3 years experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality system role.
Knowledge of local regulatory/code requirements Knowledgeable in Industry Best Practices for quality and compliance related topics Ability to process technical information.
Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems) A proactive and collaborative work style and the ability to work with multiple priorities and deadlines.
The ideal candidate will have - 5 years experience in a pharmaceutical/ regulated background with strong working knowledge of GMP, regulatory expectations, and familiarity with aseptic processing.