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Position Title

validating manufacturing

Primary Skill

Validation

Other Skills

Validation Plan CSV Risk Assessment Test Scripts

Duration

12 +Months

Position Type

Contract

Location

Evansville (Mount Vernon) Indiana,

Description

Experience with validating manufacturing execution systems and/or related
S88 recipes is a plus


• 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









Mark
Syscom Technologies, Inc.
Phone: 703-565-2313
Fax: 703-991-5645
m...@syscomtechinc.com

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