Kindly Send Resumes to adem@vertigonconsulting.com
Position: Validation Specialist
Location: Hopewell, NJ
Duration: 6-12 months
Face to face must after phone interview.
• 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
• Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
• Ability to create documents to an existing document standard.
• Working knowledge of Documentum.
• Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Thanks & Regards
Adem
Technical Recruiter
Vertigon Consulting
Phone: 201-786-2670
Fax: 732-398-0506
Email: adem@vertigonconsulting.com
URL: www.vertigonconsulting.com
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