QA Specialist

Summary:
A QA Specialist is required for a biotech company in Dunboyne. The incumbent will provide support for change control, deviation management and supplier quality management.

Responsibilities:

• Participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
• Participate in and lead investigation of deviations, risk assessments and changes, ensuring appropriate actions are implemented timely.
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
• Provide QA oversight to GMP readiness, technical transfers, regulatory approvals 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.
• Assist 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.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture on site.
• Ensure the escalation of compliance risks to management in a timely manner.

Qualifications & Experience:

• Bachelor’s degree, or higher (Science/Quality/Technical).
• 4-5 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
• Previous 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.
• Experience in direct interactions with regulatory agencies during site inspection.
• Previous experience working in a sterile/low bioburden environment.