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OT Qualification Engineers

5.00 to 7.00 Years   Chennai, Hyderabad, Kolkata, Mumbai City   16 Mar, 2022
Job LocationChennai, Hyderabad, Kolkata, Mumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryManagement Consulting / Strategy
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Job Opening Details back to list Reference Code: SR0262 Job Title: OT Qualification Engineers Category: Understanding of Agile methodologies At least 5 years of relevant experience in the above areas Educated in Business discipline or Computer Science to degree level, or equivalent experience Expertise in suite of Quality systems with atleast 5 of hands on experience in GAMP5, CSV, 21 CFR Part 11 and Annex 11 guidelines and related processes Hands on documentation experience (Validation Plan, Project Plan, Functional Risk Assessment, GxP Assessments, URS/BRD, FRS, Configuration & Design Specifications, Installation, Operational & Performance Qualifications (IQ, OQ & PQ), Training Plans, Release Notes, VSR etc.) Agile software development methodologies e.g. Scrum and SAFe Enterprise Quality Systems rollout experience from both IT and Business perspective in the role of a CSV and Qualification Engineer Experience to work with Release manager and Release Management activities. Key Skills: Understanding of Agile methodologies At least 5 years of relevant experience in the above areas Educated in Business discipline or Computer Science to degree level, or equivalent experience Expertise in suite of Quality systems with atleast 5 of hands on experience in GAMP5, CSV, 21 CFR Part 11 and Annex 11 guidelines and related processes Hands on documentation experience (Validation Plan, Project Plan, Functional Risk Assessment, GxP Assessments, URS/BRD, FRS, Configuration & Design Specifications, Installation, Operational & Performance Qualifications (IQ, OQ & PQ), Training Plans, Release Notes, VSR etc.) Agile software development methodologies e.g. Scrum and SAFe Enterprise Quality Systems rollout experience from both IT and Business perspective in the role of a CSV and Qualification Engineer Experience to work with Release manager and Release Management activities. Location: Ahmedabad, Bangalore, Chennai, Delhi, Hyderabad, Kolkata, Mumbai, Pune Required Experience: 5-7 yrs Positions: 1 Contact Person: Sethuraman Email ID: hidden_email Qualification:,

Keyskills :
quality systemsrelease notesrisk assessmentsoftware development methodologies

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