QA Specialist

ref. 01195

QA Specialist

Be part of our client’s QA team in this state-of-the-art biologics manufacturing facility located just outside Dublin.
This position primarily supports Change Control, Deviation Management, and Supplier Quality Management, along with interfacing SAP with IP| Product structure and MES BOMs and recipes. Other tasks involve supporting Quality Systems and QA Operations as per the start-up schedule.
The QA Systems and Compliance Team collaborates closely with Operations, Engineering, Validation, Supply Chain, and AR&D Functions.

Responsibilities
• Daily participation on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
• Lead and participate in investigation of deviations, risk assessments and changes, ensuring the correct actions are implemented timely.
• Provide oversight for GMP readiness, regulatory approvals, technical transfers and clinical operations at the facility.
• Assist in the development of training curricula and records for QA and providing SME training on Quality Assurance SOPs as required.
• Contribute in the creation and maintenance of QA SOPs, metrics and reports in line with site requirements.
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Prompt escalate compliance risks to management when necessary.

Requirements
• Bachelor’s degree, or higher in Science, Quality or Technical.
• Min 4-5 years’ experience,preferably in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
• Prior experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
• Previous experience in quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc.
• Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
• Direct experience in interacting with regulatory agencies during site inspection desirable.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Previous experience working in a sterile/low bioburden environment desirable.