- Management of QA activities over Batch reviews, affiliate site investigations including outsourced laboratories, NCR reports on third parties and vendors and review of quality reports for injectable sites.
- Manage day to day administration and updating of QMS for the regional QA team in line with quality policy and support product launch and ascertain quality stability data.
- Manage affiliate sites for QA product launch activities.
- Provide QA training to QA staff both internal and external in line with GMP practices and procedures.
- Review equipment, process, method validation protocols and reports, and stability protocols and reports when required. Review of Technical Agreements and Confidentiality Agreements when required.
- Preparation and review of SOPs for QA (Regional) and Affiliate Sites. Assist in Continuous Improvement projects with the sites.
- Liase with clinical, manufacturing and packaging sites as required assisting with any continuous improvement efforts across the site and any other affiliate sites.
- Bachelor’s degree in science related discipline with 8 years in a QA position in a medical device or pharmaceutical company.
- Must have knowledge of NCR, CAPA and deviation management, handling and reporting.
- Knowledge of Quality Control testing is essential. Experience in troubleshooting within a QC laboratory background is desirable.
- Knowledge of Validation and Aseptic manufacturing an advantage but not essential.
- Knowledge of Pharmaceutical QMS Systems.
- Knowledge of Quality Risk Management Systems.
- Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent