Advanced Analytics -- Validation Engineer

Posted 10 Oct 2019

Bangalore SBS, Karnataka - India

Req Id 198462

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Job Location: Electronic City, Bangalore

General description
Assists the IT Compliance Office in audits and validation related to implementation/upgrade of new/existing application services in a qualified environment. Safeguards all aspects of compliance, follows-through standards, legal, regulatory and audit requirements.

Key Responsibilities

•    Reports into the Compliance Office, assists in quality reviews and audits, performs change requests and documentation, ensures the fulfillment of the compliance requirements.
•Implement and execute IQPs, process enhancements
•    Supports ticketing and incident resolution with problem-solving mentality, capable of handling incidents proactively. 
•    Maintains HPALM and updates office and validation relevant documents as needed, ensures items are securely kept, current and accurate 
•    Performs versioning, updates and testing of IT system/application/service documentation 
•    Supports in all knowledge management aspects, such as trainings, lessons learned, cabinet updates and maintenance, knowledge transfers, debriefing


Skills:

  • Experience 2- 5 years
  •  Bachelor with specialization in Information systems, Computer Science or electronic engineering. 
  • 2+ years professional experience as a software engineer, application developer, IT service/operations engineer, capable to understand the Big data technology landscape.
  • At least 2 years of expertise in Incident/Change/Release management with experience in SDLC and LEAN Six Sigma methodologies. Good to have certification in LEAN Six Sigma.
  • Good hands on experience with HP ALM or similar, set-up workflows, manage signature flows, document/defect lifecycle and changes, liaise with other team members during the project lifecycle phases. 
  • Good Knowledge on QC Workflows with Organization administration, Customization, Data Loader, Reports, Workflow & Approvals.
  • Knowledge of system qualification and software validation frameworks, implementation of Healthcare legal requirements (GxP, 21CFR, OECD, ICH) good manufacturing practices and IT system validation methodology.
  • Understand the business requirements and preparing the documentation with strong adherence to compliance and follow the SLA/ETA standards. 
  • Should have good communication and writing skill, ability to write quality defects, creating documentations, 
  • Good Knowledge on Data Migration, Testing with Validation, defect creation and standard defect resolution processes.
  • Execution of application/project activities according to plan, preparation, creation, execution and closure of the validation activities and maintaining the standard practice of documentation on each phase.
  • Excellent troubleshooting, analytical, and problem-solving skills, pro-active attitude, Taking ownership and Stand-up in case of issues/ improvement suggestions.

 


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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