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Senior Quality Assurance Executive

Job description

Responsibilities:

  • 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.

 

Qualifications:

  • 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:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent