Job Title: QA Specialist
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This role involves providing quality assurance oversight to drug substance manufacturing operations. As a QA specialist, you will be responsible for ensuring compliance with cGMP and corporate SOPs.
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About the Role:
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In this position, you will provide QA support to technology transfer and commercial manufacturing operations. Your responsibilities will include reviewing SOPs, risk assessments, change controls, and other documentation associated with drug substance manufacturing operations.
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Your Responsibilities:
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1. Provide QA support to technology transfer and commercial manufacturing operations
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2. Review SOPs, risk assessments, change controls, and other documentation associated with drug substance manufacturing operations
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3. Ensure that drug substance manufacturing operations are conducted according to appropriate cGMP behaviors and in compliance with SOPs, batch manufacturing records, and other cGMP documentation
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4. Liaise with manufacturing operations to ensure that all deviations, investigations, and batch manufacturing record reviews are performed, addressed, and closed out in a timely manner
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5. Work with manufacturing operations to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to manufacturing operations are addressed and closed out in the required time frame
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6. Liaise with manufacturing operations, QA, QC, Engineering, MSAT, etc. in supporting daily operations
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7. Ensure clear communication on issues and timely escalation as applicable
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8. Identify opportunities for continuous improvement
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9. Support internal Quality peers to ensure on-time disposition of drug substance material
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10. Provide support for the preparation of regulatory submissions and inspection readiness activities
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11. Perform onsite quality monitoring of GMP areas
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12. Provide support for health authority inspections including responses to inspection observations, monitoring of follow-up actions
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About You:
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We are looking for an individual with a Bachelor's degree in a technical discipline (e.g., biochemistry, chemistry, engineering). Candidates from Manufacturing Operations, Validation, Engineering, and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered. Demonstrated experience in Quality Management System, pharmaceutical regulations, and continuous/process improvement tools is required.
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What We Offer:
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* Bonus
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* Canteen
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* Parking
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* Pension
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* VHI
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We Are:
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An organization where people of all backgrounds and experiences are respected. We work together focused on changing lives.
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