Writing and editing test methods procedures (SOPs), validation/qualification reports/protocols and development reports for analytical methods.
Application of technical experience and understanding of CMC or analytics into the writing or reviewing of documents.
Generation of Excel templates and macros to allow for the generation of consistently formatted tables and graphs.
Must work effectively in a team environment, with individuals at all levels within the organization. Collect and interpret feedback to be incorporated into documents.
Write relevant compliance and operations related SOPs, generate technical templates etc. and professionally format documents.
Experience writing technical documents for a CMC related area, preferably in method development/validation or product characterization with experience working a GMP regulated area.
Must have excellent planning, organization, and time management skills.
Must have a strong technical comprehension and writing capability along with verbal communication skills.
Expert in Microsoft Word, Excel and PowerPoint
Must have excellent attention to detail and ability to generate professionally formatted documents
The desired candidate will have the ability to work independently with limited supervision.
Source: Job Diva – Job Listing