*JobTitle: IT Validation Analyst. Duration: 6 Month location:Cambridge, MA *
Job Requirements
As a member of the IT Quality & Regulatory Compliance team, the IT Analyst
Regulatory Compliance helps to define, plan, and perform duties that
support major system development life cycle activities, including
validation review and change control approval of IT systems.
PRINCIPAL DUTIES & RESPONSIBILITIES:
Approve system life cycle deliverables and activities to ensure that
regulations, protocols, procedures, and methodologies are followed, and
that appropriate and complete documentation is captured and reported to
support validation activities.
Represent IT Quality & Regulatory Compliance on cross-functional teams in
support of SDLC activities.
Consult on the authoring and conformance of validation-related deliverables
and activities in regard to corporate SOPs and current regulations.
Provide guidance, training, and support to IT personnel in their validation
efforts, to ensure compliance.
Provide quality assurance oversight for system related issues (deviations,
incidents, etc.)
QUALIFICATIONS:
Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11)
regulations and guidelines
Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL
Excellent communication skills, both verbal and written
Detailed knowledge of the IT system development life cycle and software
quality assurance in a regulated environment
Experience with risk analysis and risk management practices and tools
Five or more years of experience in computerized system validation within a
regulated environment
Please send resume to :*nathan.j...@panzersolutions.com
<nathan.j...@panzersolutions.com>*
--
--
***************************************************************************************
For all SAP related tutorials,Articles,Faqs,Tips
www.sapbrainsonline.com
****************************************************************************************
You received this message because you are subscribed to the Google Groups
"sapbrains" group.
To post to this group, send email to sapbrains@googlegroups.com
To unsubscribe from this group, send email to
sapbrains-unsubscr...@googlegroups.com
For more options, visit this group at
http://groups.google.com/group/sapbrains?hl=en
---
You received this message because you are subscribed to the Google Groups
"sapbrains" group.
To unsubscribe from this group and stop receiving emails from it, send an email
to sapbrains+unsubscr...@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.
