Job Description
Pharmaceutical Quality Specialist Global leader in the field of Medical Devices seek to expand their team and hire an experienced Quality Specialist. Responsibilities: Assist the Quality Manager in the development of continuous improvement and compliance projects within the Quality Department. Creating and updating Quality Procedures in conjunction with operating staff, while ensuring compliance with GMP and GDP. Support the Quality Manager in maintaining compliance with GMP, GDP for the business, local and corporate procedures, regulatory requirements, and industry standards. 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. Recording, investigating and reporting incidents and deviations to the Quality Manager and Qualified Person. Assigning resources to all investigations, ensuring the acquisition of the necessary information. Ensuring implementation, closure and effectiveness of all Corrective & Preventive Actions generated. Requirements: 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. Bachelors 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. Renumeration Package: Excellent salary and progression on offer Dublin West location Hybrid work model Bonus Scheme Company Pension Scheme Paid Health Insurance Health and Well-being Allowance 20 Days Annual Leave (Increasing with service) Financial Further Education Support For more information and a comprehensive job specification contact: Olivia Rogers If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Celtic Careers is proud to be an Equal Opportunity Employer. By submitting your CV or personal details, you are providing Celtic Careers consent to process your personal data. In order to service you as a candidate this is required. Celtic Careers may contact you from time to time regarding further opportunities. Celtic Careers will not share your data with third parties without your prior consent. You can withdraw your consent at any time by emailing us at the email address above. For further information please see our Privacy Statement on our website. Skills: Quality specialist Quality Control Quality Assurance Benefits: Pension Healthcare Bonus Hybrid