EY Senior Consultant - Business Consulting Risk 

India, Karnataka, Bengaluru 

876392711

Requisition Id : 1577978

TMT :

Industry convergence offers TMT (Technology, Media & Entertainment, and Telecommunications) organizations the chance to evolve and transform, but it also presents challenges around competitiveness and delivering agile corporate strategies for growth.

CNS - Risk - Digital Risk :

Financial Services Risk - helps clients in the financial sector to identify, manage and monitor the risks in their business. It is done through a transformative and agile approach including process and procedures, risk, data modeling and analytics, reporting to stakeholders and third parties, business requirements (for software selection and IT implementation), analysis of assets and liabilities, and capital and liquidity management.

Your key responsibilities

Technical Excellence

The current vacancy is only for the role of Senior Consultants

Your key responsibilities

• 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, SAP, 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

• A graduate degree from a reputed University
• 4- 6 years of overall CSV experience
• Hands on experience of 21 CFR/ CSV

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 postivie energy, while being adaptable and creative in their approach.

What we offer

If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible.