We are seeking an experienced Quality Document/Technical Documentation Writer who is familiar with the Pharmaceutical industry, specifically one with Computer System Validation skills.
We require the writer to author multiple unfinished work products/deliverables across multiple M&A projects – e.g. Migration Plan, Migration Approach, Migration Reports. Project details and specifics will be provided to the writer by the Project Manager who oversees the work.
The deliverables (i.e. work products/technical documents produced by the writer) will be reviewed by the Project Manager & IT Quality Manager in-house for any corrections and/or edits required until a final version of the document is approved. Necessary work product templates & outline descriptions/tools will be provided to the writer.
Key to Note
Work product templates are already in place that adhere strictly to company standards. In other words: the writer does not need to author work products from scratch.
• GxP standards & regulations
• Understanding of CFR Part11 & Pharma Regulations
• Pharmaceutical industry experience
• Validation skills
• Technical Document writing skills
• Understanding of how to work with Quality Management
• Ability to deal with ambiguity and achieve clarity.