QA Operations Specialist

Summary:
A QA Operations Specialist is required for a biopharmaceutical in Dunboyne. The QA Operations Specialist role involves supporting the operational activities, technical transfers, regulatory approvals and commercial operations on site.

Responsibilities:

• Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing 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).
• 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.
• Liaises with internal partners (e.g. Manufacturing Operations, Process Development Technical services (PD-TS), Engineering functions etc) in support of daily operations.
• Ensures clear communication on issues and timely escalation as applicable.
• 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.

Qualifications & Experience:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• 4+ years experience in QA.
• Must be able to work across a team matrix in order to meet accelerated timelines.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Excellent communication skills (written and oral).
• 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.
• Exceptional analytical, problem solving & root-cause analysis skills.
• Experience with working in a multinational organization.