Technical Writer, Document Author, Document Writer (with IT experience)

Role Description

We are seeking an experienced Quality Document/Technical Documentation Writer who is familiar with the Pharmaceutical industry, specifically one with Computer System Validation skills. Experience of working within and IT department or function is essential.

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

* Experience of working within and IT department or function

• Ability to deal with ambiguity and achieve clarity

Compétences : Rédaction Technique, Rédaction de Rapport, Rédaction Médicale, Audit, Content Audit

Concernant le client :
( 3 commentaires ) Macclesfield, United Kingdom

Nº du projet : #34859508