This is a 9 month contract
The Supply Chain QA Specialist role will involve continued development of the facility’s Quality Assurance Incoming Release strategy, ensuring the processes conform to the company’s policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world. Close collaboration with high performance talent from the company’s global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will inspire his/her team to build the future of the company’s biologics through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide. Providing training and guidance on the interpretation and implementation of the company’s policies and regulatory requirements will also be key priorities for the Specialist. Throughout the development of the new facility, the successful candidate will focus on supply chain compliance, incoming material qualification, supplier complaints and changes, supplier transparency and incoming material release.
• Be involved in material qualification though gathering, review and approval of supplier documentation.
• Be responsible for the quality aspects of receipt and release of incoming materials for the site.
• Raise and manage change controls that reflect the suppliers’ changes – to ensure that changes are communicated, evaluated, risk-assessed, and implemented in a manner consistent with the company’s policies. Liaise with supplier to accurately evaluate and implement the suppliers’ changes. Participate in Material Review Board activities to control such activities.
• Raise and manage supplier complaints to assess and resolve issues with incoming materials; work with the supplier to prevent future recurrences.
• Be involved in all quality-related activities for the warehouse and dispensary which are required by the company’s Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity. Including quality review and approval of deviations, change controls and Standard Operating Procedures (SOP’s).
• Raise and manage change controls for BOMs, and routings for internal manufacturing (in conjunction with the SAP Process and Data stewards).
• Manage or participate in Supply Chain-focused and cross-departmental projects as needed.
• Will work closely with stakeholders and SMEs from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
• Liaise with above site groups for material and supplier management.
• Responsible for adhering to site and above site KPI, tracking and reporting of same.
• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career within the company.
• This role requires a QA Specialist with a minimum of 5 years’ experience in Quality Assurance or Supply Chain, Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
• A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Preferred to also have a background in Quality Control Testing including method validation/verification/qualification or Supplier Management.
• The motivation to be an inspiring member of a high performing team.
• The desire to continuously learn, improve and develop
• A great communicator, decisive decision maker and proven ability to deliver excellence.
• Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Experience with new product introductions and/or process qualification/technology transfer.
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