Quality Specialist

A Quality Specialist is required by CareerWise Recruitment for our Dublin 12 based client. Reporting to the Quality Manager, 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.

THE ROLE:

• Support the Quality Manager/ Responsible Person and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) for Medicinal Products, Company 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 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
• Demonstrated ability in quality systems support.
• Knowledge of EU quality related pharmaceutical regulations
• Experience of a MIA environment
• Experience in dealing with 3rd 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. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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