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 3^rd Party quality audits
• Managing Plant Master Files and Dossiers
• Excellent computer skills