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. The role will report to the Quality Manager.
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.
Core Responsibilities: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.Define and periodically update Quality Procedures in conjunction with operating staff, ensuring compliance with GMP and GDP.Prepare information in advance for presentation at the Quality Review Board meetings.Assist in the completion of internal audits of GMP/GDP systems, assessing and verifying planned corrective and preventive actions.Ensure the GMP and GDP elements of the Quality Management system (QMS) are understood by providing training to company personnel regarding updated documents.Record, investigate, and report incidents and deviations to the Quality Manager and Qualified Person.Assist Process Owners in assessing risks and assigning counteractive measures.Conduct Supplier Audits and Assessments, as required.Manage and update Technical Agreements.Document and manage relevant change controls through to completion.Ensure adherence to the stability schedule.Manage stability data for the support of expiry dates.Coordinate customer and supplier complaints, including investigations, reporting, and trending.Assist in the coordination and documentation of product recalls and mock recalls.Support Pharmacovigilance, Medicovigilance, and Compliance activities as required.Issue protocol and report numbers and maintain associated logs.Compile reports in a timely manner, as requested.Assign resources to all investigations, ensuring the acquisition of necessary information.Ensure implementation, closure, and effectiveness of all Corrective & Preventive Actions generated.Requirements:Bachelor's degree or higher preferred; ideally in a related Science discipline.Demonstrated ability in quality systems support.Knowledge of EU quality-related pharmaceutical regulations.Experience in a MIA environment.Experience in dealing with 3rd party warehouse distribution models.Minimum of 3 years' experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in a 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.Accuracy and excellent attention to detail are key attributes along with strong organisational skills.Proven ability to effectively initiate and drive change.Proficiency in the English language; strong verbal and written communication skills are essential.Report, standards, and policy writing skills required.Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems).A proactive and collaborative work style with the ability to work with multiple priorities and deadlines.Project Management Skills.Ability to work as part of a team to determine priorities.Demonstrated ability to work independently and realize improvement initiatives with moderate guidance.Demonstrated ability to drive the completion of tasks.Proven decision-making capability with accountability and responsibility.Demonstrated ability to solve problems.The ideal candidate will have 3 - 5 years' experience in a pharmaceutical/regulatory background with strong working knowledge of GMP, regulatory expectations, and familiarity with aseptic processing.
For full details contact Linda at +353 1 2784701 or email your CV to ******. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
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