A Quality Compliance Specialist is required by Careerwise recruitment to work with our Dublin based pharmaceutical client.
Role of this position
- Ensuring GMP-impacting systems are maintained as per written procedures.
- Becoming a key member of the audit / inspection teams during external cGMP audits and inspections, e.g., corporate audits and regulatory authority inspections.
- Assisting in implementation of Global Standards and Procedures into the site Quality Management Systems.
- Actively supporting the development and implementation of continuous improvements to the QMS.
- Participating in Quality Risk Assessments periodic reviews.
- Oversight and preparation of Key Performance Indicators to align with company and global quality objectives.
- Assisting in and facilitating completion of deviation investigations as part of the site Deviation Management System, ensuring effective root cause analysis and appropriate CAPAs.
- Bachelor's degree in chemistry, biology or a related scientific discipline.
- Experience working in sterile / aseptic manufacturing pharmaceutical facilities.
- A minimum of 7 years working within Quality in the pharmaceutical industry.
- Thorough understanding of sterile / aseptic manufacturing guidelines, the Pharmaceutical Management Systems guidelines, cGMPS, EU / US / JP guidelines.
- Lead Auditor training and experience leading internal audits.
- Knowledge of finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, process development, and manufacturing operations.
N.B. It is essential that you hold a valid working visa for Ireland
Please call Michael O'Connor today for further information on 091-452410 or email firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)