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 and
Provide coaching and mentoring to operations personnel and to other QA reps on appropriate risk management to provide appropriate and timely solutions to compliance in a business focused fashion.
Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, 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, sampling protocols and Annual Product Reviews.
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 can be discussed further during the interview process.
For further details please contact;Paula O’Reillyon 087 7094141 or send CV in confidence to
Expected salary
Location
Cork
Job date
Thu, 18 Jul 2024 05:40:59 GMT
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