QA Specialist / QP
Harry Walsh Associates Ltd
Cork
To manage and drive the site QA systems in conjunction with other Specialists in the QA Product Quality team. To coordinate all QA duties relating to QP batch release and communicate all issues relating to batch release schedule in a timely manner to schedule, manage and deliver the batch release schedule in compliance with Regulatory requirements and GMP guidelines. To proactively identify and implement industry best practices including but not limited to internal processes that support manufacturing, quality control, materials management, validation and quality assurance. Essential Responsibilities. Responsible for 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. Ensure that all necessary production and quality control documentation has been completed and endorsed by authorized staff. Maintain oversight of deviations and change controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required. Pro actively participate in the QMR process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required. Continuous improvement of the quality systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective. Experience: 5 Years’ experience within a regulated environment. 3rd level qualification in Science / Engineering discipline. Eligibility to act as a Qualified Person in line with local and EU directives. Next Steps: Apply now by clicking the “Apply” button below. Not quite ready to apply, or have some questions first? Call Evelyn 021 436 8330 to discuss this role in confidence. “Finding the right job for you....your job your location and your salary!” This job originally appeared on RecruitIreland.com.
2326 days ago