Quality Assurance Specialist – Validation and NPI
An amazing opportunity has arisen for a Quality Assurance Specialist to join the quality team within a leading Biopharmaceutical Multinational. As a member of the Tech Transfer/Validation Team you will play a vital role in supporting the introduction of new products and Quality oversite of executed validation completed at this Carlow based facility.
Responsibilities:
• Provide quality oversight and direction for the introduction of new products.
• Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
• Participate as a functional expert in the cross-functional team responsible for introducing products
• Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
• Review documentation associated with new product, such as, QC Test Specifications, BOMs, and MES documentation.
• Support deviation close out in a timely manner.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with others
Qualifications and Experience:
• A Bachelor's degree or higher in a related Science discipline is preferred.
• A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
• Experience in reviewing and approving documents associated with Equipment Validation, Cleaning validation, Sterilization such as Autoclaves and other equipment like CTU's, Isolators etc.
• Quality oversite of equipment Qualification and knowing how to review and approve the following documents IQ, OQ, PQ, IOC, IOQ's etc.
• Experience of systems Kneat, IPI, Veeva Vault would be an advantage.
• Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
• Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
• Strong report, standards, and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired. For more information and a full job spec contact Nicola on () or email your CV in the strictest confidence to (email address removed)
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