Hybrid, Senior QA Specialist with Pharmaceutical experience.

  • Meath

Hybrid, Senior QA Specialist with Pharmaceutical experience.

Excellent contract opportunity in a Global company with wonderful opportunities for progression.

Apply today


  • Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
  • Participate in investigations and risk assessments related to deviations/ complaints 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 the Microbial and Analytical Method Validation, Analytical/ Microbial Technical Transfers, Regulatory approvals, Clinical and Commercial operations at the facility.
  • Support QA operational duties related to product disposition including the performance of detailed review of eBR prior to QP release and Material release.
  • Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
  • Participate in and support risk management activities in line with relevant guidance and best industry practice.
  • Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture in BioNX.
  • Ensures the escalation of compliance risks to management in a timely manner

Skills and Education:

  • Degree qualification (Science/Quality/Technical).
  • 5-10 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
  • Project Manager capability with significant understanding of Operations.
  • Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
  • Strong written and verbal communication skills.
  • Ability to think logically and be proactive under pressure.
  • Ability to work as part of a team and on own initiative in a constructive manner.
  • Strong attention to detail and precision in preparing and reviewing GMP documentation

CAPA QMS gmp change controls technical transfer Project Management pharmaceuticals

To apply for this job email your details to rachel@rtlanerecruitment.ie.