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Assistant Manager - QA Compliance

Keywords / Skills : Assistant Manager - QA Compliance

Posted: 2019-09-27

Industry
ITES/BPO
Function
Manufacturing/Engineering/R&D
Posted On
27th Sep 2019
Job Ref code
COR011737
Job Description
Job Description :

. Responsible for implementing & maintaining Genpact PVAI Quality Management System (QMS).
. Responsible for managing the compliance of Service Delivery Framework based out of ISO 20000 / ITIL
. Provide QA and process expertise within development team and Quality Assurance.
. Help the QA team in defining processes needed for the QMS
. Coordinate & support internal and external audits
. Accountable for ensuring there are NO/less non conformances during external audits.
. Manage CAPA / Deviations to effective closure
. Collect track key metrics / KPI to improve processes
. Provide any process training or QMS trainings and maintain oversight on the training process
. Support in implementing the QMS processes and agreeing on any tailoring for the release/project.
. Ensures that development team are following the agreed process which meets both external and internal requirements
. Conduct toll gate reviews
. Collaborates with other stakeholders in Genpact to direct compliance issues to appropriate existing channels for investigation and resolution.
. Help the QA to achieve targets based on the QA strategy, approach and execution in development projects.
. Additional tasks as assigned by the Quality Lead

Qualifications
Minimum qualifications

Graduate/ Post Graduate
Experience in software quality and a minimum relevant experience in healthcare/pharma domain. Demonstrable working knowledge of GAMP 5 Guidelines, ISO 9001, FDA Part-11 & ITIL/ISO 20000 standards and general financial, procurement, quality assurance, and human resource procedures

Preferred qualifications



Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws.

Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit YouTube (https://www.youtube.com/user/GenpactLtd) .



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