Wyeth Pharmaceuticals (now Pfizer) | Technical Writer (S.C. Foster Contract)
Malvern, Pa. | 2006 to 2007
Led documentation effort as the group moved from using TrackWise to the new SAP Corrective and Preventive Action (CAPA) Enterprise System before its deployment to sites within this global pharmaceutical organization
- Conducted weekly meetings with core North American Investigations Users Group (NAIUG) to obtain information for use in written materials for SAP CAPA Business Process improvement initiative
- Worked with Quality System Owners to revise and obtain approval for documents
- Researched internal Conformance Standards, Division Directives and other documents to provide
consistently accurate materials - Received internal training on the SAP CAPA Enterprise System, GXPharma (Documentum), and cGMP
- Collaborated with SMEs to develop a global list of SAP CAPA reportable event and root and contributing cause listings
- Circulated and sought approval for Division Guidance drafts through GXPharma
- Wrote directive detailing the process for running internal IMR (Integrated Monthly Reports) in SAP CAPA
- Collaborated with coworker to comprise a glossary detailing the entire new SAP CAPA System
TYPES OF DOCUMENTS DEVELOPED
- Division Directives/Guidances
- Standard Operating Procedures
- Tutorials
- User Specifications
- Test Scripts
- Glossaries
About Pfizer:
Industry: pharmaceuticals, biotechnology
Company Size: 10,001 +