Manufacturing Execution System Quality Associate
3 days ago
This role involves an initial 6-9 month secondment in Lilly Kinsale to gain hands-on experience and training at an established site before transitioning permanently to Lilly Limerick. The successful candidate will be responsible for ensuring the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. They will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Responsibilities and Requirements
Develop and maintain quality assurance procedures, policies, and systems for the MES. Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations. Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process. Investigate and address deviations, non-conformities, and CAPA to maintain quality associated with MES quality events. Participate in IT, production, and process automation organizations to provide consistency across all manufacturing execution systems. Ensure regulatory compliance by staying current with industry regulations, guidelines, and best practices. Maintain accurate records and reports related to regulatory compliance. Maintain accurate and comprehensive quality records, change control documentation, and quality reports. Develop common local procedures for MES and support review and approval of GMP documents associated with qualification and validation for MES. Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes. Participate in risk assessments and quality improvement projects. Communicate and educate personnel in GMP requirements and regulations related to MES. Stay informed about the latest developments in eBRs and quality assurance. The ideal candidate will have a strong understanding of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements. They will also possess excellent problem-solving and analytical skills, as well as effective communication and teamwork skills.
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