WHAT IS TIGHTWRITE?
I am an independent consultant with 30 years experience in the pharmaceutical manufacturing field. I specialize in providing high quality solutions for your GxP documentation needs.
TECHNICAL WRITING
Error Proofing and Best Practices
QUALITY SYSTEMS CONSULTING
QMS Implementation
QUALITY REVIEW
Attention to Detail
EXAMPLES OF PAST PROJECTS
PATHEON
SOP Redesign and Harmonization
Created a new template and style guide for global PQS documents and consolidated site-specific quality systems SOPs into the new format. This involved taking 3-6 site documents and combining the best aspects of each into a single, global document used by sites in Canada, Europe, and the U.S.
GENENTECH, SAMSUNG, TOLMAR
Batch Record Redesign
Revised manufacturing batch records to address compliance gaps, remove redundancies, and for ease of use and best practices to reduce errors.
ROCHE
Global PQS Document Improvements
Revised content and adjudicated user feedback for global PQS documents, for processes such as Validation, Batch Release, Stability, APQR, etc.
Ensured relevant health authority regulations were cited/footnoted appropriately
Served as Document Manager for shepherding documents through the global change control process involving stakeholders in Europe, Asia, and the Americas
BRISTOL-MYERS SQUIBB (ZYMOGENETICS)
Simplifed CMC Filing
Reconciled a BLA filing and multiple amendments into a simplified, current state eCTD. This included the original filing plus 5 major amendments and several smaller ones, for both Drug Substance and Drug Product CMC sections.
