QA Compliance Specialist

2022-01-10 10:54:582049-05-26Team Horizon
Job TypeContractor
Start Date
AdvertiserAshling Guthrie
Job Ref#2295
Job Views66
We are currently recruiting a QA Compliance Specialist on a contract basis to join our clients diverse Quality Control team in Dublin. The Compliance Specialist-QA is responsible for the co-ordination and oversight of activities required to maintain and improve compliance at the. The Compliance Specialist will be responsible for risk assessing and enhancing quality management systems, data management and control systems at the manufacturing site. The incumbent supports systems such as TrackWise Deviations (non-conformances), CAPAs, Change Control, SAP/POMS, Documentation management systems and other software applications, as needed.
Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
  • The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
  • Excellent career progression opportunities.
What you will bedoing:
  • Represent the site Quality Assurance department as SME in compliance
  • Manage/input into SAP/POMs refinement initiatives.
  • Liaise with Site BTS and Operations functions as necessary to support compliance initiatives
  • Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, Manufacturing and IT areas.
  • Track and provide relevant quality metrics to Quality Management as required
  • Perform quality risk assessment of all GMP documentation systems and support stakeholders in the mitigation of compliance  risks.
  • Prioritize risks and work with all site departments to ensure documentation and system compliance
  • Be current with regulatory requirements (FDA, HPRA) and possess a working knowledge of the documentation lifecycle Management in accordance with 21CFR Parts 210, 211,  11/ Annex 11, ICH Q9,Q10, GAMP5 and all applicable regulatory requirements
  • Ensure alignment between the local and global compliance and QRM initiatives
  • Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill company requirements
  • Write or review and approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate
  • Initiate action reports or deviation reports for any applicable nonconformance
  • Seek process innovation and continuous process improvements
  • Recognize and report to immediate supervisor any issues or deviations from accepted standards
  • Provide status updates on own activities and productivity challenges according to defined procedures
  • Complete and conform to all training requirements for job role, including company-required and job role-specific training
  • Carry out and assist in the ongoing training of new and existing personnel, as appropriate
  • Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses
What you need to apply:
  • A third level qualification in Science, Engineering or related discipline, preferably a bachelor’s degree
  • Relevant industry experience (5+ years) including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology or medical device industry
  • 3+ years of experience in a quality assurance role.
  • Experience in compliance requirements for validating IT systems in accordance with regulatory Data Integrity controls including 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9, Q10, GAMP5 and all applicable regulatory requirements
  • SAP or ERP system experience
  • Excellent communication and interpersonal skills, including technical writing
  • Strong analytical and problem-solving skills
  • Maintain credibility and integrity.
  • Goal focused
  • Demonstrate passion and energy
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