Full Time

CSV (computer System Validations)

Posted 3 months ago by Mphasis Limited
Application ends: July 13, 2022
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Job Description

Role : Application Designer
Role Description : Assist in defining requirements and designing applications to meet business process and application requirements.
Must Have Skills : CSV (Computer System Validations)
Good To Have Skills : No Technology Specialty
Job Requirements :
Key Responsibilities : Understand clients CSV, Quality and Risk management strategy, define and align with the processes and procedures for the program/project Assist in strategic inputs during define phase of CSV projects Able to arrive at tactical and operational measures to ensure client commitments have been met Help Accenture / clients to successfully deal with either internal or external audits concerning IT Quality and Compliance Provide industry domain knowledge for all resources in a project enabling

Technical Experience : Considerable experience in IT project CSV and proven ability to lead validation activities of complex IT projects This should include: understanding the business; determining business system requirements; regulatory understanding of FDA, MHRA and other key regulations, project planning; cost estimation, assigning validation project responsibilities; negotiating project deliverables Good communication skills, both verbal and written Ability to engage, interact and negotiate effectively

Professional Attributes : Provide SME support on topics relevant to GxP, CSV, 21 CFR Part 11, Annex 11 etc Liaise with other relevant teams such as SOX experts, Data Privacy and Contract Compliance to holistically handle compliance program Assist in developing strategic processes and procedures to align with client requir

Educational Qualification : a BE completed

Additional Information : Moderate experience in defining and managing large compliance programs for Life Sciences clients
Salary: Not Disclosed by Recruiter

Industry:IT-Software / Software Services

Functional Area:IT Software – QA & Testing

Role Category:QA/Testing/Documentation

Role:Quality Assurance/Quality Control Manager

Employment Type:Full Time, Permanent
Business processComplianceProject planningLife sciencesdata privacyCost estimationOutsourcingRisk managementOperationsMHRA