Dear Partners,

Please send resumes with rate and contact information to [email protected].
Please mention the position for which you are applying.
Local candidates preferred as F2F may be required. For outstation
candidates, candidates will have to bear all expenses of F2F interview.

*Position 1*
*
-----------------------------------------------------------------------------------------------------------
*Location: South Jersey
Duration: 6+ months
*Pharmaceutical exp a MUST!
*
*Position*: Validation Specialist
Individual to provide support for SAP Support Pack implementation project

6+ years experience
• Apply FDA, MHRA, and other applicable global regulations to the
development of computer systems supporting regulated business processes
• Follow SOPs and industry best practices
• Conduct training on good documentation and good testing 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
• Review computerized systems validation documents such as:
o Requirements Specification
o Design Specification
o CSV Risk Assessment
o Test Plans
o Test Summary Reports
o Data Migration Plan
o Pre/Post Executed Test Scripts
o Traceability Matrix
o Release to Production Statements
• Direct and review testing
• Provide guidance on quality issues that affect the integrity of the data
or the system
• Prepare validation summary and test summary reports
• Obtain and respond to QA review
• Participate in establishing standard quality and validation practices
• Independently assess compliance practices and recommend corrective actions
• Approve validated computer system related change requests
• Monitor regulatory and inspection trends and advise the business on
suitable action

*Position 2*
*
-----------------------------------------------------------------------------------------------------------
*Location: South Jersey
Duration: 6+ months
*Pharmaceutical exp a MUST!*

Position will require SAP Material Ledger Functionality (Actual Costing) and
configuration for a new SAP implementation for Russia. Candidate will be
required to complete the analysis and design documents associated with this
specific functionality and implement, test and support during the life of
the project.

Thank you and best regards,

-- 
Kumar
BrunsTEK LLC ||| People. Services. Trust
Work: (732) 543-8693
Email: [email protected]
Website: www.brunstek.com

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