QA Operations specialist
Shift 16/7
RK26587
Contract 9 months
Meath


We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Meath. 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.


The QA Operations Specialist role involves supporting the operational activities, technical transfers, regulatory approvals and commercial operations at the single use multi-product biotech facility.


Key Responsibilities:

• Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations.
• Liaises with internal partners (e.g. Manufacturing Operations, Process development Technical services (PD-TS), Engineering functions etc) in support of daily operations.
• 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).
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility.
• Review/Approval of validation/Qualification/verification protocols and reports associated with new product or material entry.
• Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.
• Responsibility for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviors, and performance and budget management.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• 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.

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• 4+ years experience in QA.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
• Experience in performing internal audits and participating in external audits.