Senior QA Specialist
This innovative speciality biotech organisation is a leading science-based bio-pharmaceutical company based in the U.S that discovers, invents, develops, manufactures, and commercialises medicines for the treatment of serious medical conditions. This organisation commercialises medicines for eye diseases and rare inflammatory conditions and has product candidates in development in other areas of high unmet medical need. Employing north of 4,000 staff globally with an annual R&D spend of $1 billion, this organisation is consistently being voted one of the top innovative biotech organisations globally.
This role will perform manufacturing record reviews, determine disposition of final products and ensure compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.
- Prepare appropriate documentation and execute release of acceptable product lots and vendor materials.
- Review completed manufacturing, filling, and labelling records, and analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Review, edit, and approve deviation notifications, deviation investigations, and corrective actions.
- Review, edit, and approve new and revised master manufacturing records.
- Review, edit, and approve validation protocols and executed protocol reports.
- Audit production and other departments for quality system effectiveness.
- Perform hands-on monitoring of production and non-production activities and notify area and Quality Management.
- The successful Senior QA Specialist will have a BSc/BEng in a scientific discipline or related field.
- 3+ years of relevant work experience in pharmaceutical or related industry.
- Biologics manufacturing experience highly desirable.
To learn more apply on line or call Preneta Naidoo on +353 1 6321870.
Salary: On Application