Senior Qa Associate

A Production QA Senior Associate is required to join a leading global Pharmaceutical organisation in Cork with hybrid working. The focus of the role is to provide QA ownership for products manufactured in your area of responsibility.


The Role Provide Quality leadership, direction and governance.Perform ongoing monitoring that includes: Monitoring of quality systems, production area time on floor audits, verification of the effective implementation of key GMP programs.Provide coaching and mentoring to operations personnel and to other QA representatives on appropriate risk management to provide timely compliance solutions in a business-focused manner.Review and approval of key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, and process flow documents.Review and approval of change controls, observations/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, stability data, and sampling protocols. The Person Hons BSc, MSc, or PhD in Chemistry, Engineering, or related discipline, with a minimum of 2 years Quality experience in a production role.Pharmaceutical industry experience is preferred.Experience working in cross-functional teams and proven ability in decision-making.Demonstrates ability in critical thinking, data analysis, problem-solving, and experience in root cause analysis.If you have a preference for shift positions, this can also be explored and discussed further during the interview process.

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