Career Centre

Technical writer

Location

Job Description:

*Project/Department Description and responsibilities :
ITS Global Quality & Compliance ensures that ITS operates in compliance with the various external and internal regulations like the US Sarbanes-Oxley act, FDA CFR 21 Part 11, the IAPP (Information Asset Protection Policy) and other.

*Environment Development Tool(s) and Platform(s) :
All current Information Systems infrastructure tools and platforms that ITS is supporting

*Primary Tasks and responsibilities :
Technical writing aspects of:
Implementation and maintenance of Standard Operating Procedures, work instructions and templates - Audits of ITS Process, Projects and Technical area. Writing of audit reports and coordination of corrective actions -

*Technical profile requirements :
Computer System Validation (CSV) methodologies for information systems, you have applied CSV methodologies in practice within an information systems deployment or support activity (+5 years), preferably in the pharmaceutical industry - Sarbanes-Oxley SOX) regulation, you have worked in environments that are subject to SOX and participated in activities that ensure SOX compliance (+3 year) - Good Manufacturing/Clinical/Laboratory Practices (GxP) regulation, you have worked in environments that are subject to GxP and participated in activities that ensure GxP compliance (+3 year) - You can easily analyze processes, draw flow chart diagrams and describe processes in clear language. You have excellent (technical) writing skills (+3 years)

Qualification Rating
JJ PRO IM
CSV *

4 (Very Strong) of 5 (Expert)
and 5+ Yrs.
GxP *

2 (Limited Experience) of 5 (Expert)
and 3+ Yrs.
SOX *

2 (Limited Experience) of 5 (Expert)
and 3+ Yrs.
Technical Writing *

4 (Very Strong) of 5 (Expert)
and 3+ Yrs.

Non Technical Skills and Additional Details