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QA Systems & Training Ops Analyst GxP

2.00 to 5.00 Years   Hyderabad   21 Feb, 2020
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaStatistics / Analytics
EmploymentTypeFull-time

Job Description

Your responsibilities include, but are not limited to:Manage user accounts for global Development (ESOPs, DevQMS, LMS Space).Release training assignments in LMS Space (P&SP, WP, SOP, BG, WBT, and ILT) based on applicability s in STAR. Training systems document maintenance: Update effective SOP docs in LMS Space, process document withdrawals, assign ESOPs contributor roles. Provide technical or administrative support for users. Adhere to the global LMS Admin guidelines 6. Ensure harmonization of LMS usage in global Development 7. Participate in LMS Space Business User Community. Provide Compliance audit support for QA. Perform validation activities - PQ testing, manage change control, etc. Manage LMS Space communications for global Development. Support STAR infrastructure updates as requiredMinimum requirements What you ll bring to the role: Degree in science, or related experience Fluency in English (oral and written). Min. 5 years in pharmaceutical industry, preferably development 2. Skilled with computerized data systems; familiarity with Pathlore LMS and Saba LMS or other learning management system a plus. Experience working with a learning management system. Experience working with MS Excel and Excel macro programming, preferred. Experience working in a GxP environment. Experience and/or understanding of quality systems. Demonstrated leadership in implementing robust quality systems in a regulated area. Strong interpersonal, communication, negotiation and problem solving skills; strong project management skills. Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.,

Keyskills :
global drug developmentchange control problem solvingquality systems drug developmentmanagement system project managementlearnin

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