Quality Specialist

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.

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. For example - Support projects as the business expands within the compounding services division.
• Defining and periodically updating Quality Procedures in conjunction with operating staff, while 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 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. Conducting Supplier Audits and Assessments, as required.
• Managing and updating Technical Agreements
• Documenting and managing relevant change controls through to completion.
• Ensure the adherence to the stability schedule.
• 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.
• Support Pharmacovigilance, Medicovigilance and Compliance activities as required.
• Responsible for issuing protocol and report numbers and maintaining associated logs.
• Compilation of reports in a timely manner, as requested. Assigning resources to all investigations, ensuring the acquisition of the necessary information.
• Ensuring implementation, closure and effectiveness of all Corrective & Preventive Actions generated.  

Requirements:

• Bachelor’s degree or higher preferred; ideally in a related Science discipline
• The ideal candidate will have 3 - 5 years’ experience in a pharmaceutical/ regulated background with strong working knowledge of GMP, regulatory expectations, and familiarity with aseptic processing.
• Demonstrated ability in quality systems support.
• Knowledge of EU quality related pharmaceutical regulations 
• Experience of a MIA environment
• Experience in dealing with 3^rd party 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.
• 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 is essential. Report, standards, policy writing skills required.
• 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.
• Project Management Skills
• Ability to work as part of a team to determine priorities.
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
• Demonstrated ability to drive the completion of tasks
• Proven decision-making capability with accountability and responsibility.
• Demonstrated ability to solve problems.

For full details contact Linda at +353 1 2784701 or email your CV to ldunne@thornshaw.com. Thornshaw Scientific is a division of the CPL Group