Job Description

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Role Purpose \
\ * Directly manage assigned projects to satisfy specific project/client needs - Plan, schedule, execute assignments wrt validation and 21 CFR Part 11 GXP compliance testing procedures
\ * Performing Compliance evaluation of procedures and systems wrt computerized systems used in GLP, GMP environments.
\ * Coordinate with cross-functional project teams in for deliverables within the agreed timeline.
\ * Support development of best practices within the validation group, based on current industry practices and guidelines.
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Do \
\ * Understand the system via review of technical documentation.
\ * Provide timely update of status to Wipro and Client Partners.
\ * Extensive knowledge of test scripting and execution.
\ * Execution of Regulatory Compliance Projects (documentation and execution of 21 CFR Part 11 or EU Annex 11 compliance). Validate developments & updates of GxP apps (POMSnet, Maximo, OSI PI, SampleManager, Empower, Trackwise, ComplianceWire, Antares, Warehouse Serialization Solution, Discoverant). Track and capture using qTest validation tool
\ * Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
\ * Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
\ * Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.
\ * Identifies nonconformities of product or process standard and offers recommendations for resolving deviations.
\ * Develops, maintains, or reviews validation and compliance documentation.
\ * Modifies testing methods or revisits test objectives and standards to resolve testing problems.
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\ * Behavioral Competencies\

\ * Formulation & Prioritization
\ * Client centricity
\ * Execution Excellence
\ * Passion for Results
\ * Confidence
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Deliver \

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Work experience & skills \
\ * Familiarity with GxP systems (POMSnet, Maximo, OSI PI, SampleManager, Empower, Trackwise, ComplianceWire, Antares, Warehouse Serialization Solution, Discoverant)
\ * Experience with qTest (ALM) execution.
\ * Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
\ * Experienced with various technologies and automated systems used in the pharmaceutical industry - Business System (ERP etc), Quality System (Track wise, LIMS etc) etc
\ * Experienced with tools - electronic document management systems Confluence; application development and lifecycle management qTest.
\ * Experienced or Knowledge on automated tool - TOSCA
\ * Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
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Academic & trades qualifications \
\ * Bachelor\'s degree in engineering / Master?s Degree in science.
\ * Minimum 5 years? of relevant validation testing experience in pharmaceutical/biotech manufacturing or testing.
\ Industry 4.0

Wipro