Sr. Spclst, Quality Assurance
Core
Qualified Person (QP) responsible for batch release, product quality compliance, and regulatory adherence for biopharmaceutical manufacturing.
Role type
Senior regulatory quality specialist (Qualified Person)
Builds
Ensures GMP compliance and batch release for solid drug manufacturing (tablets, implants) for livestock and domestic animals.
Domain
Biopharmaceuticals / Regulatory Quality / GMP
Required skills
GMP knowledge, regulatory compliance, batch release decision-making, CAPA assessment, change control review, complaint management, document creation and approval, inspection readiness, quality reporting
Preferred skills
None stated
Technologies
None stated
Responsibilities
Issue Certificates of Analysis (CoA) and Certificates of Compliance (CoC), assess product quality deviations and CAPAs, review product quality reports, manage QP/QAO documentation, support inspection readiness
Seniority
Senior, hands-on IC
