About the job

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 escalate issues clearly and appropriately.

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Responsibilities

About the job

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 escalate issues clearly and appropriately.