My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of the company, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. At their campus at Cork, they employ approximately 600 staff and are a 24/7 operation exporting to 93 markets worldwide.
As QA Specialist/QP, you will manage and drive the site QA systems in close cooperation with other specialists in the QA Product Quality Team. You will coordinate and execute all QA duties relating to QP batch release and communicate all issues.
• Coordination of the certification of finished product batches to the market as required under the EU directive 2001/83/EC
• Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing Authorization
• Maintain oversight of deviations, CAPA & Change Controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required
• Continuous improvement of the manufacturing and quality systems – Identifying and building in efficiencies as necessary from a systematic and compliance perspective
• Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business needs
• Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice.
Qualifications and experience
• 3rd level qualification in Science / Engineering discipline or equivalent knowledge or experience
• Significant experience within a GMP / QA environment in a pharmaceutical company or similar regulated environment
• Eligible to act as a Qualified Person in line with local and EU directives.
• Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization
• Excellent communication, negotiation and risk based decision making skills, promoting openness, dialogue and collaboration
• Results oriented with a strong ability to effectively troubleshoot and problem solve issues
• Promote a continuous improvement culture.