Advanced Analytics -- Validation Engineer

Job description

Advanced Analytics -- Validation Engineer

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.

 

Job Requisition ID: 198462

Location: Bangalore SBS

Career Level: C - Professional (1-3 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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