About this opportunity
Pharmatek Consulting Inc. lists this CSV Engineer/Analyst opportunity in concord, New Hampshire. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Concord, United States | Posted on 07/30/2024
Industry Pharma/Biotech/Clinical Research
Job Type Full time
Work Experience 5+ years
City Concord
State/Province North Carolina
Country United States
Job Description
General lab instrumentvalidation requirements. worked in a lab or have done lab validationbefore for at least a year or 2
CSV expert for that one.
Needsto be a strong personality.
Needs to be onsite 4 days a week.
Needsto be able to create all different validation documents as well as know dataintegrity
10 plus years experience
Requirements
Responsible for supporting thevalidation activities for local and global systems.
Experience in developing andmaintaining validation documentation including validation plans, testprotocols, test scripts, and summary reports to align with company SOP andregulatory standards.
Coordinate with technicalevaluation with site subject matter experts (SMEs) of new andexisting systems from a DI and CSV perspective.
Responsible for coordinating withcross-functional teams to ensure the alignment of the validation activities.
Perform data integrity gapassessment and develop remediation plan for computerized systems.
Responsible for creatingCAPA’s/Deviations and Change Requests in ServiceNow and Trackwise
Experience using HPALM forauthoring and executing the Test scripts.
Experience inperforming/supporting computer validations associated with SDLC deliverables
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Worksite address
concord, NH, 03306, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.