QA Operations Specialist
Fully onsite
RK26404
Contract 6 months
Meath



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Louth. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



This role will be responsible for supporting the clinical and commercials operational activities, at the single use multi-product biotech facility. You will work across site teams to resolve issues and drive quality, EHS, learning, and continuous improvement, while ensuring compliance with cGMP and corporate regulations.



Key Responsibilities:

• Provide QA oversight to the clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing and support process technical transfers, analytical technical transfers, drug substance disposition and regulatory approvals.
• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
• Liaises with internal partners (e.g. Manufacturing Operations, MS&T, Engineering functions etc) in support of daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Helps maintain site practices and procedures related to clinical and commercial operations.
• Responsibility for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, and performance and budget management.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
• Representing Quality on multidisciplinary teams.
• Executing company policies.
• Ensures new/revised quality system requirements are deployed to the Site.
• Ability to work on his/her own initiative in addition to working as part of a team
• Possess strong problem solving and trouble shooting skills

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in the biotechnology and/or pharmaceutical industry.
• Previous Experience with deviation management/Change controls
• Previous Experience in Batch Record Review is preferable
• Knowledge of cGMP regulations both domestic and international.