Computer Software Validation Specialist
- Perkin Elmer India
- 2 - 5 years
- Mumbai
- 5 years ago
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Job Description
Job Title Computer Software Validation SpecialistLocation(s) Mumbai
Purpose:
As a Computer Software Validation Specialist, you will be a valued team member of Global Quality Systems to lead and support validation program activities in the implementation of new or upgraded systems, applications and technologies per PerkinElmer corporate and site initiatives. As part of a small team and under minimal supervision, candidates will be responsible for providing both automated and manual testing for new software as well as enhancements and defects addressed in existing software.
Responsibilities:
- Develop and review documentation (protocol, plans, test scripts, reports etc.) associated with the implementation and maintenance of computerized systems.
- standard compliance methods in support of validation activities (e.g. good documentation practices, statistical sampling, review or inspection, testing and test management, root cause analysis).
- Execution of test plans, automated test scripts and test cases to ensure that software meets or exceeds specified standards, development specifications, and/or client requirements.
- Clearly communicate validation strategies and facilitate all aspects of a risk - based life cycle approach for Computer System Validation projects
- Facilitate and document risk as it relates to the implementation of new technology, systems, and tools (e.g. intended use, functional risk), as well as changes to existing.
- standard compliance methods in support of validation activities (e.g. good documentation practices, statistical sampling, review or inspection, testing and test management, root cause analysis).
- Work closely with Business, Quality and IT professionals to ensure software validation tasks, activities and deliverables are completed within defined time commitments.
- Work with the users and developers to identity areas for improvement
Requirements:
- A BA/BS degree (Information Technology, Scientific, Business Administration or a related field is preferred)
- A minimum of five (5) years of related experience working in validation - related activities.
Desired:
- Knowledge of the regulations as they relate to Computer System Validation (e.g. 21 CFR Parts 11, 820, Medical Device Directive, ISO 13485)
- Demonstrated ownership of Computer System Validation (CSV) activities, including quality of deliverables and adherence to project timelines
- Results - driven with excellent organization, prioritization, and time management skills
- Excellent written and verbal communication skills, with a proven ability to effectively communicate and lead within a regulated environment
- Functional experience in a large ERP (e.g. SAP, ServiceMax) software environment is a plus
- Fundamental knowledge of a typical development cycle from requirement through development and testing, and through production implementation and support
- Hands - on experience testing: Javascript, jQuery, HTML5, CSS, and 3rd party API usage
- Experience with Microsoft C#, Microsoft .NET Core, ASP.NET, and ASP.NET Web API
- Experience with SQL Server Management Studio and SQL Profiler (preferred)
- The candidate should be self - motivated and be able to work without supervision
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: IT Software - Application Programming, Maintenance,
Role Category: Programming & Design
Role: Programming & Design
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Post Graduation Not Required
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required
Contact Details:
Company: Perkin Elmer IndiaLocation(s): Mumbai
Keyskills: ERP SAP jQuery Manual testing Test scripts Javascript Test cases microsoft Information technology SQL
Perkin Elmer India
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategica...
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