Consultant - Business Consulting Risk - TMT - CNS - DIGITAL RISK
EYGBS · Mumbai · onsite · Posted 30d ago
Undisclosed8–13 yrsfulltimeSourced from
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About this role
Job Summary
Responsibilities
Technical Excellence
Skills and attributes for success
To qualify for the role you must have
Qualification
Experience
What we look for
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
The opportunity: Consultant-TMT-Business Consulting Risk-CNS - RISK - DIGITAL RISK - Mumbai
Responsibilities
Technical Excellence
- Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)
- Create/ review CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reports
- Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems
- Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle
- Review and approve computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables
Skills and attributes for success
Experience in Quality and Compliance with hands-on computer system validation experience on Enterprise Applications (LIMS, ERPs, LMS, RPA, CTMS etc.)
Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
Experience with validation/ testing tools like HPALM, Azure DevOps (ADO) etc. will be an added advantage.
Experience in training validation resources will be an added advantage.
To qualify for the role you must have
Qualification
- Bachelor of Technology in Computer Science
- b pharmacy
- Bachelor of Computer Applications
Experience
- csv 2 to 13 years
What we look for
People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. We look for people who are agile, curious, mindful, and able to sustain positive energy, while being adaptable and creative in their approach.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Business ConsultingDevopsAzure DevopsAgileCGMPerpsCatalystenterprise applicationsBusiness RequirementsCSVAnalyticsEnterprise RiskInternal Auditbusiness strategyFinancial ServicescomplianceMicrosoft AzureData Modeling
About EY Global Delivery Services ( EY GDS)
EYGBS
Accounting & Auditing
40.0k+
employees
2002
24 years old
Bangalore/Bengaluru, Karnataka
India
₹15.5L PA avg
Avg at EY Global Delivery Services ( EY GDS)
About
EY Global Delivery Services (GDS) is a truly global delivery network of over 74,000 people working across the border to provide innovative and strategic business solutions to EY member firms.
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