QA Operations Specialist

Job Description

QA Operations Specialist

Location: Dunboyne, Ireland

This is a shift-based role with rotation across the week, 40 hours per week.

Responsibilities

• Work closely with cross-functional teams to address compliance issues in a timely manner.
• Participate in investigations and risk assessments related to deviations, complaints and changes, ensuring appropriate actions are implemented to meet deadlines.
• Provide QA review and approval of change controls, deviations/CAPAs, SOPs and related documentation for compliance with GMP and site requirements.
• Provide QA oversight for qualification/validation, technical transfers, regulatory approvals, laboratory operations and commercial operations.
• Perform material disposition of incoming material to the site.
• Assist in developing training curricula and records for the QA operations group, providing SME training on Quality Assurance SOPs as required.
• Support continuous improvement by identifying and implementing efficiencies and quality improvements.
• Collaborate to foster strong relationships with management and colleagues to drive a safe and compliant culture on site.
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
• Ensure timely escalation of compliance risks to management.
• Keep informed of the latest developments from regulatory authorities in relation to quality compliance.
• Support cross-functional departments by responding quickly to unplanned events and technical issues.
• Perform real-time exception review by maintaining on-floor operations support during manufacturing.
• Attend site walk-throughs and GEMBA process as assigned.
• Possess knowledge of contamination control processes and assist in identifying/mitigating contamination risks to ensure optimal product quality and compliance with regulatory standards.

Qualifications

• 4-7 years of experience, ideally in Quality Assurance, Quality Control or Technical Operations within the biological and/or pharmaceutical industry.
• Experience with PAS-X, SAP and Veeva is desirable.
• Project manager capability with significant understanding of operations and/or laboratories.
• Demonstrated experience in QRM, investigations and problem-solving as a Quality SME.
• Strong written and verbal communication skills.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Ability to think logically, be proactive under pressure, and work both as part of a team and independently in a constructive manner.
• Knowledge and application of industrial regulations including FDA, HPRA, EMEA and other authorities related to biologics and/or pharmaceuticals.
• Experience in direct interactions with regulatory agencies during site inspections.
• Candidates must be available for flexible shift pattern and on-site full-time duty.
• Shift position will involve a rotation across up to 7 days with a maximum working week of 40 hours; start and end times will vary by shift.