Project Description
Quality and Regulatory Affairs Professional
Over 25 years experience in various quality and regulatory roles within the pharmaceutical, API and medical device industries. A versatile and fastidious quality professional with very strong experience as a regulatory affairs administrator, documentation reviewer and auditor in contract and full-time roles.
Highly experienced in compiling regulatory submissions, PQR/APR. Has effectively managed a number of quality systems including customer complaints and failure investigation. Is also a qualified lead assessor.
Skills and Experience:
- Audit and review of batch and quality documentation and specifications
- Compilation of PQRs/APRs and Annual Reports
- Liaising with regulatory agencies
- Complaint and Failure Investigation Quality System management
- Internal and vendor quality auditing. Assisting with 3rd Party quality audits
- Managing Plant Master Files and Dossiers
- Excellent computer skills
Information
LOCATION
Based in North Tipperary and available to work in the Clare, Limerick, Galway, Tipperary and Cork areas.