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

Role

  • 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

Skills:
CAPA QMS gmp change controls technical transfer Project Management pharmaceuticals

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