- Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
• - You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
• - Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
• - Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation
• - Requirement Specification document review and approvals
• - System Implementation Plan Review
• - System Implementation Summary Report Review
• - Review and Pre-Approve ST/UAT Test Scripts in ALM
• Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
• Post Execution Review and Post Approvals in ALM
• - gR Implementation Approvals
• - Retirement Plan Revew
• - Retirement Summary review Deliverables:
• - Requirement document
• - Validation/Test Plan
• - Requirement Traceability Matrix
• - Change Requests
• - Impact assessment document
• - Test/Validation Summary Report
-
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Lab Software Compliance Specialist
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Omni Inclusive Princeton, United StatesJD: · Responsibilities · • Gather and document business and functional requirements for IDMP workstream. · • Complete the review and approval of all business and functional requirements in ALM. · • Participate in the updating of the Regulatory Risk Assessments for requirements in ...
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Ask Staffing Princeton, United StatesJob Title: · Business Analyst/Manufacturing · Location: Princeton, NJ, 08543 · Duration: 6 Months · Pay Rate: $51/ hr · Description · One BA is needed to support RTMS site implementations covering the following workstreams: · 1.) Manufacturing, Warehousing and Quality Assur ...
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Innova Solutions Trenton, United StatesSpecialist, MSEO Manufacturing Systems Validation · - Engineering · Job ID: · Summit , · New Jersey · Job Type: · Contract · Added - a day ago · Job Description · Innova Solutions is immediately hiring for an MSEO Manufacturing Systems Validation Specialist · Position Typ ...
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Capacity East Brunswick, United StatesCapacity LLC "does not" offer any kind of visa sponsorship for this role, now or in the future (e. g. OPT, H1B, etc...). · ***This position is based out of North Brunswick, NJ. · [Please note this is a Direct Search led by Capacity. Applications from agencies will not be accept ...
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Capacity New Brunswick, United StatesCapacity LLC "does not" offer any kind of visa sponsorship for this role, now or in the future (e. g. OPT, H1B, etc...). · Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button. · ***This posi ...
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Ascent Services Group Summit, United StatesInnova Solutions is immediately hiring for an MSEO Manufacturing Systems Validation Specialist Position Type: Contract Duration- 06 Months Location- Summit, NJ As an MSEO Manufacturing Systems Validation Specialist, you will: Work cross-functionally to execute validation activiti ...
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Validation QA Analyst
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buyer
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CSV Analyst - Princeton, United States - Katalyst Healthcares and Life Sciences
