Experis, part of the Manpower Group is recruiting for a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
This position reports to the Associate Director Quality and will be part of the Quality Organisation based in Carlow.
The Quality Assurance Specialist role supports the introduction and execution of new products and direct materials into the Carlow facility.
- The QA Specialist (NPI and Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities. .
- Responsible for ensuring new material introduction process is followed and acts as quality partner with supply chain management.
- Act as Quality point of contact for all drug substance queries both internally and externally
- Provide quality oversight and direction for the introduction of new products and materials onto site covering the end to end strategy.
- Performs quality reviews of documentation associated with new product and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.)
- Complete the Quality deliverables for material and product introduction process, including, assessment / update of Quality Agreements, review /requesting supplier audits, generation of product specification files.
- Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- Development & monitoring of supplier performance metrics. Actively participates as a member of Material Review Board and Quarterly Business Review of key suppliers, and other cross functional forums as requested.
- Support the development and implementation of improved quality reporting measures. Aid the effective implementation of the Quality Management System, and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions.
- Partner with colleagues cross functionally to provide support and advice on day to day basis and on a project basis including communications, training, project work, investigations and customer queries.
- Review and verify site documentation that may be used for submission to CMC or other requester(s) for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program.
- Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.
- Ensure reliability and performance by facilitating effective systems for identification of root cause failures, recommendations and implementation of improvement changes throughout.
- Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues
Education and Experience:
- Bachelors Degree or higher preferred; ideally in a related Science discipline
- 3 years experience in a similar quality assurance role in a regulated, GMP environment
Our client demonstrate a commitment their employees by offering a competitive and valuable rewards program.
If you would like to discuss this role please contact Sandra on 01 6455250 or 086 044 3460 or email