QA Specialist
Core
Oversee quality assurance activities for the manufacturing and disposition of bulk drug substances at the Athlone facility, ensuring compliance with cGMP and regulatory requirements.
Role type
Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
Commercial and clinical bulk drug substances
Domain
Pharmaceutical manufacturing / Biopharma
Required skills
cGMP knowledge, GMP management, validation protocols, quality risk assessment, deviation and CAPA management, change control, vendor/supplier management, raw material qualification, inspection readiness, quality metrics reporting
Preferred skills
sterility assurance, auditing, regulatory inspection management
Technologies
Trackwise
Responsibilities
Provide quality and cGMP input and oversight for all manufacturing activities; Review and approve technical support documentation (cleaning, process, method validation); Review and approve functional area documentation (SOPs, Work Instructions, technical reports, protocols); Participate in quality risk assessments; Review and approve Validation protocols; Support inspection readiness activities and interact with health authority inspectors; Review and approve Master Batch Records; Oversee QMS activities including Preventive Maintenance, Deviation, CAPA, and Change Control; Provide quality oversight of calibration and preventative maintenance; Author, review, and approve Quality Related Procedures; Support Vendor/Supplier and Raw Material Qualification Programs; Develop and report quality metrics; Oversee documentation and tracking of QMS activities.
Seniority
Mid-level, hands-on IC
