Senior Quality Assurance Specialist - Drug Substance

Cytokinetics
Ireland
Full Time
Hybrid
Senior
EUR 78,400 – 98,000
Bachelor Degree
Healthcare Healthcare Life Sciences

Posted 2 weeks ago

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Excellent 4.7

Job summary

The Senior Quality Assurance Specialist - Drug Substance conducts batch documentation reviews, oversees manufacturing and testing processes, manages deviations and regulatory audits, and supports quality improvements in a biopharmaceutical setting.

Responsibilities

The Senior Quality Assurance Specialist provides GMP oversight for manufacturing and distribution activities at Contract Manufacturing Organizations. They are responsible for reviewing batch documentation, managing quality events like deviations and CAPAs, and supporting product release and regulatory compliance.

Qualifications

batch documentation review CAPA management Change control management Deviation management GMP regulations Investigation handling Oral solid dose pharmaceutical manufacturing Quality Management System (QMS) Regulatory inspection readiness Veeva, TrackWise or similar eQMS

Candidates must hold a bachelor's degree in a scientific or technical discipline and possess at least 5 years of experience in the biopharmaceutical industry. A minimum of 3 years in GMP Quality Assurance and a strong working knowledge of FDA, EMA, and ICH regulations are required.

English

Company

Cytokinetics

Cytokinetics

linkedin
Biotechnology Research
Location
Ireland

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Excellent 4.7
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