Senior QA Specialist

Job Description

I am seeking a Senior QA specialist for a well-known and respected global pharmaceutical company based in Dublin for a 1-year FTC.

I am seeking a Senior QA specialist for a global pharmaceutical company based in Dublin for a 1-year FTC. This person will be responsible for ensuring that operations and operating procedures are compliant with all cGMP regulations and guidelines.

The successful person will have a BSc in Science with a minimum 5 years' experience in a QA role coming from a pharmaceutical background ideally in QA, QC or manufacturing operations for drug substance or drug product. Knowledge of cGMP in relation to API desirable. Strong customer focus and communication skills essential for the role. Working alongside CMOs desirable.

Responsibilities:

• Oversee drug substance batches for clinical trials.
• Oversees investigations and out of specs to ensure they are complete efficiently.
• Assist in RCA investigations providing a quality insight on deviations.
• Oversee change control activities including documentation, process, equipment, and facility.
• Complete internal cGMP walks downs and support on-site inspections by external regulatory bodies.
• Generate and complete annual product quality reviews.
• Oversee cGMP documentation.
• Oversee supplier management activities.
• Complete QA data integrity tasks.
• Assist in validation activities including process, equipment, and facility.
• Promote continuous improvements through programs and projects.
• Training QA technologists as needed.

If this role is of interest, please apply now.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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