QA Operations Specialist TPM6114

Summary:

We currently have an opportunity for an experienced QA Operations Specialist for a biopharmaceutical company in Dunboyne. The successful candidate will provide quality oversight of clinical and commercial operations, ensuring compliance with cGMP and applicable regulatory requirements.

Responsibilities:

• Provide QA oversight of clinical and commercial operations, including Quality Control, Supply Chain, Engineering and Manufacturing activities.
• Provide quality support for process and analytical technical transfers, drug substance disposition and regulatory approval activities.
• Support the effective execution of the site Quality Management System, including CAPAs, change controls, deviations and batch documentation review.
• Work closely with Manufacturing Operations, MS&T, Engineering and other site functions to support daily operations and resolve quality issues.
• Coordinate with Quality teams to support the timely disposition of commercial drug substance.
• Ensure clear communication of quality issues and timely escalation where required.
• Maintain and improve site practices and procedures supporting clinical and commercial operations.
• Ensure adherence to domestic and international GMP regulations, cGMP requirements and applicable company policies.
• Monitor quality metrics, support the achievement of site targets and ensure appropriate corrective measures are implemented when required.
• Represent Quality on cross-functional and multidisciplinary teams.
• Support the deployment of new and revised Quality System requirements across the site.
• Promote quality, EHS, learning and continuous improvement across site teams.
• Work independently and collaboratively to investigate issues and deliver effective solutions.

Qualifications & Experience:

• Degree or postgraduate qualification in Science, Pharmacy or a related discipline.
• Minimum 3 years' experience within the biotechnology and/or pharmaceutical industry.
• Previous experience with deviation management and change controls.
• Experience in batch record review would be advantageous.
• Knowledge of domestic and international cGMP regulations.
• Understanding of Quality Management Systems, including CAPAs, deviations, change controls and batch documentation.
• Strong communication skills with the ability to escal ate issues clearly and appropriately.