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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Assurance Operations (Hybrid)


Reference:RK22264 Location: Meath
Qualification:DegreeExperience:7-9 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Quality Assurance Operations (Hybrid)
RK22264
Contract – 11 months
Meath


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties:

  • 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 qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
  • Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release.
  • Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
  • Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
  • Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements.
  • 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.
  • Assist in the execution of the internal audit programme including the performance of audits are required.
  • Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
  • Ensures the escalation of compliance risks to management in a timely manner.




Experience and Education:

  • Degree qualification (Science/Quality/Technical).
  • 8-10 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.


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.