QA Specialist

at  PE Global

EDUCATION 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.
• 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.
• 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.
• Strong decision-making capability with a sense of accountability and responsibility.
• Demonstrated problem-solving skills

THE ROLE:

PE Global is currently recruiting for a Quality Assurance Specialist on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role.

RESPONSIBILITIES:

• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
• 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 and materials at Carlow.
• 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 and material introduction, such as Material Packs, QC Test Specifications, BOMs, and MES documentation.
• Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed.
• Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used at Carlow.
• Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.