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Details

Senior QA Specialist


Reference:AOORAGML-877473 Location: Cork
Cork City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Senior QA Specialist


Description
My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. In 2019 (Pre-Covid), our production volume was ca 32 mill units (vials) and supported turnover across the Supply chain of -USD 55OM. The plant has ~600 employees.


The Senior QA Specialist is responsible for providing technical support and direction in the following areas: quality systems implementation and maintenance, adverse trends and quality issues, regulatory compliance and regulatory intelligence standards, which impact the manufactured and marketed products from the client's Cork facility.


The Senior QA Specialist will operate within multi-disciplinary departments both internally and externally and is required to build strong relationships with same.


The Senior QA Specialist reports to the QA Leader of Quality Systems.


Main Duties and Responsiblities

  • Executing the processes associated with the deployment of global policies and site quality procedures. Ensuring quality and site procedures are up to date and reflective of regulatory & industry requirements.
    • Proactively participate in the GMP Meetings process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required.
    • Continuous improvement of the quality systems – including but not limited to PQRs, Quality trends, Metrics Reporting, Change Control, Supplier Management and Training.
    • Review and approve validation documentation and ensure compliance to regulatory standards.
    • Provision of quality oversight for services and operations which are outsourced to CMO's / contract labs.
  • Implementation and execution of the processes of internal and external inspections, including Inspection readiness preparation, inspection execution and ensuring non- conformances are actioned & progressed to closure in a timely manner.
  • Support Quality Improvement Projects on-site.
  • Lead and participate in Data Integrity and Quality Risk Management assessments.
  • Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice.

Behaviours
  • Effective communication skills with demonstrated ability to work in a matrix environment.
  • Strong decision maker based on risk level is a key competency of this role
  • Ability to multi-task & handle tasks with competing priorities effectively.
  • Excellent communication and negotiation skills promoting openness, dialogue and collaboration.
  • Results-orientated with a strong ability to effectively troubleshoot and problem solve issues.
  • Promotes a culture of continuous improvement.

Principal Qualifications and Experience Required
  • 5-7 Years' experience within a regulated environment.
  • 3rd level qualification in Science/Engineering discipline.
  • Excellent level of knowledge of Quality Management Systems, Quality Risk Management, Data Integrity, GMP regulations, sterile manufacture, packaging guidelines, QC operations, technical transfers and process automation.
  • Strong knowledge of regulatory/GMP requirements and standards.
  • Ability to provide technical support and guidance to the QA Specialists.

For further information, contact Alan O Riordan on +353 87 365 7522 / alan.oriordan@lifescience.ie