QA Specialist

PE Global is currently recruiting for a QA Specialist for a leading multi-national Pharma client based in Carlow.

This is a contract position.

Role:

• 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.

Requirements:

• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***