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Lilly unites caring with discovery to make life better for people around the world.
For more than 138 years Lilly has been committed to bringing life-changing medicines to those who need them, advancing the understanding and management of disease, and supporting communities where we live and work.
We re proud of our heritage, and at our manufacturing site in Kinsale, we value integrity, excellence, and respect for people.
Provide Quality leadership, direction and governance for the specific area of responsibility
Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in the area of responsibility
Approval/review of batch records.
For biopharma supporting role, provide support to the QP for batch certification of Biotech drug substance materials OR for pharma supporting roles, perform batch disposition activities (API material)
Review and approval of change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
Review and approval of GMP documents associated with qualification and validation including, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes
Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents
Approval of raw materials, intermediates and packaging components used in the manufacture of pharmaceutical products, using SAP
Evaluation, audit and approval of 3rd party vendors of raw materials, intermediates and packaging components.
Participation in internal and external audits
Communication and education of personnel in GMP requirements and regulations.
BSc (Hons) Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline with ideally a minimum of 2 years QA experience.
A proven track record in current role is essential.
Previous experience in a pharma/biopharma GMP production environment essential, preferably in a quality role or a relevant technical support role.
Strong analytical and technical skills.
Problem solving skills resolution and prevention measures.
An excellent teamwork approach.
Guidance of others through processes.
Very strong communication and people skills interaction with production, engineering, suppliers, other sites.
Flexibility to change.
Ability to network internally and externally to benchmark processes/systems