Cindy has experience with project management, cGMP working knowledge, and technical writing. She provides technical writing and quality oversight in support of commissioning, validation, SOPs, INDs, and protocol development. Cindy has extensive experience working with cross functional teams advising, preparing, and submitting INDs, Amendments, Annual Reports, Response to Questions, Package Inserts and Drug Labeling, as well as writing and executing SOPs, and coordinating and assisting team members during writing, editing, negotiating, and final sign-off of documents.

 

• Creates and updates Standard Operating Procedures for various clients.

• Supports the development/ revision of commissioning/ validation protocols (FAT, IQ, IOQ, OQ, PQ, and Validation Master Plan).

• Updates and maintains PTSI electronic library in support of technical writing projects for clients.  

• Manages cGMP document library for PTSI project projects.

• Provides technical writing support for GMP Documentation.

• Ensures that documentation is complete, recorded, and compliant with cGMP regulations.

• Meets with clients, vendors, and PTSI SME’s in developing, revising, proofing SOP’s, validation protocols, and presentations.