*GLP and GCP validation testing experience Required*

*Location:          Hopewell, NJ*

*Duration:          6 months*

* *

*GLP and GCP validation testing experience Required*

* *

• Follow SOPs and industry best practices
• Facilitate the Computer system Validation Risk Assessment to identify
governing regulations and validation deliverables during the development of
the computer system
• Review validation deliverables for projects which are contracted to third
party suppliers
• Maintain close communication with stakeholders and team members to keep
apprised of computerized system needs, impacts on computer validation,
project validation status, and other relevant issues
• Assist in planning, implementing, and documenting user acceptance testing
• Prepare computerized systems documentation such as
o Validation Plan
o CSV Risk Assessment
o Test Plans
o Test Summary Reports
o Test Scripts
o Traceability Matrix
o Validation Summary Reports
• Review testing; may execute test scripts
• Provide guidance on quality issues that affect the integrity of the data
or the system
• Obtain and draft responses to QA review
• Assess compliance practices and draft recommendations for corrective
action
• Maintain a working knowledge and awareness of regulatory requirements
• Organize validation documentation and prepare for archival






-- 
Regards,

kalyan venkatesh
Sr.IT Recruiter
Softpath Systems, Inc.|Maiden Lane, NY-10038
Voice:  212-405-1894 x 104 | FAX:(212)-405-1895
Email : [email protected],[email protected]
URL : www.softpathsystems.com


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