Consultant
Year Noida, Uttar Pradesh, India
Job Description
Job Duties
Key components of the responsibilities are as mentioned below:
- Provide application validation expertise on Adverse Event Reporting products including Argus Safety, ArisG, Oracle AERS, Clintrace and related modules
- Be accountable for authoring Validation Plan, Traceability Matrix and Validation Summary Reports
- Requirements Analysis and Risk Assessment, Profiling and Mitigation
- Development, Execution, Approval and Monitoring of the Qualification (IQ, OQ, MQ, PQ scripts and protocols, results and reports) deliverables for GAMP Software categories
- Follow the cross-phase procedures and plans like Defect Management Plan, Change Control Procedure, Document Management Plan and Training Plan
- Closely work with clients and vendors to support implementation and resolve product issues
- Prior experience of Argus validation
- Professional experience and strong knowledge with real time experience in Computer System Validation / Software Testing / System Implementation in the Life Sciences industry
- Excellent communication and inter-personal skills
- Commitment to excellence and high quality standards
- Versatility, flexibility, and a willingness to work within changing priorities
- International travel readiness, work hours that overlap global client location Time-zones
- Well versed with various SDLC models and Software Test life cycle and Defect Management Life Cycle
- Knowledge of Pharmaceutical / Life Sciences/ Drug Safety domain
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Job Detail
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Job IdJD3073352
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationNoida, Uttar Pradesh, India
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EducationNot mentioned
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ExperienceYear