Life Science Recruitment
Job title:
Senior QA Associate
Company
Life Science Recruitment
Job description
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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