The Senior Quality Specialist will maintain site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Responsible for ensuring compliance with all aspects of Quality for the Limerick site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
- Responsible for review and approval of the following types of documents, relating to area functions:
- Master records
- executed records
- Failure investigations
- change control documents
- Corrective/preventative action documents
- Standard operating procedures
- Validation protocols and summary reports
- QC data
- Raw material tests
Experience and Required Skills: Education and Experience
Requires BSc/BEng in scientific discipline or related field with 8+ years of relevant work experience in pharmaceutical or related industry. Biologics manufacturing experience desired.
If you are interested in the role please apply below with an up to date CV. Not sure yet? Give me a call for more information on the company and role.
Sthree UK is acting as an Employment Agency in relation to this vacancy.