EY Consultant - Business Consulting Risk 

India, Karnataka, Bengaluru 

886801963

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.

Technical Excellence

• CSV (Computer System Validation), Equipment Qualification (CQV), Automation testers, Quality Assurance - ITRA The current vacancy is for the roles of Associate Consultants, Consultants, and Senior Consultants in the following domains (click on the link below to read JD) . The final role will be assigned based on the candidate’s interview performance and expertise.
• Computer System Validation (CSV)
• Equipment Qualification (CQV)
• Automation Testing
• Quality Assurance (QA) Key Responsibilities Computer System Validation (CSV)
• 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 plans, qualification plans, SOPs, IQ/OQ/PQ, traceability matrices, 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, ensuring thoroughness of validation planning and progress toward timely completion of validation deliverables. Skills & Attributes for Success
• Experience in quality and compliance with hands-on validation experience on enterprise applications (LIMS, ERPs, LMS, RPA, CTMS, etc.).
• Experience in FDA-regulated environments with a good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation.
• Experience with validation/testing tools like HPALM, Azure DevOps (ADO), and other validation frameworks will be an added advantage.
• Experience in training validation resources will be an added advantage. Equipment Qualification (CQV)
• Perform equipment qualification (IQ/OQ/PQ) for laboratory and production equipment in a pharmaceutical setting.
• Ensure compliance with cGMP, FDA, and industry standards for equipment and utilities qualification.
• Prepare and review validation protocols, test scripts, and final reports.
• Work closely with engineering, quality, and operations teams to support equipment qualification activities.
• Troubleshoot equipment issues and recommend corrective actions.
• Maintain qualification documentation and ensure audit readiness. Skills & Attributes for Success
• Strong knowledge of commissioning, qualifications (FAT/SAT/DQ/IQ/OQ/PQ) and decommissioning activities.
• Hands-on process engineering and/or operational experience
• Prior knowledge of working on plants operated with an MES is preferable.
• Understanding of cGMP, GMP, FDA, EU Annex 11 and other regulatory compliance requirements.
• Ability to troubleshoot equipment issues and recommend corrective actions is an added advantage. Automation Testing
• Conduct automation testing, including functional, regression, and performance testing.
• Develop and execute test scripts and automation frameworks using Tosca.
• Strong understanding of how to identify, document, and manage test defects.
• Perform testing for Salesforce applications ensuring functionality and performance compliance.
• Conduct cross-browser and cross-platform testing using BrowserStack.
• Ensure compliance with regulatory requirements in automation testing. Skills & Attributes for Success
• Experience in test automation using Tosca.
• Strong hands-on experience in Salesforce testing.
• Proficiency in BrowserStack for cross-browser and cross-platform testing.
• Strong programming/scripting skills for test automation.
• Familiarity with AI-driven testing methodologies (preferred but not mandatory).
• Knowledge of regulatory requirements related to software testing in pharma environments is an added advantage. Quality Assurance (QA)
• Ensure compliance with regulatory requirements, including FDA, MHRA, EMA, and other global regulations.
• Maintain and improve Quality Management Systems (QMS) in pharmaceutical environments.
• Prepare for and manage regulatory audits and inspections, ensuring audit readiness.
• Develop, implement, and review SOPs related to quality assurance and compliance.
• Conduct internal audits and CAPA management to ensure compliance.
• Provide training and support on quality standards, regulatory requirements, and best practices. Skills & Attributes for Success
• Expertise in regulatory compliance and QMS implementation.
• Experience in conducting and managing audits (internal and external) and regulatory inspections.
• Strong understanding of FDA, MHRA, EMA, and other pharmaceutical compliance regulations.
• Ability to develop and maintain SOPs, CAPA management, and deviation handling.
• Experience in providing training on quality assurance standards and compliance best practices.
• Certified Quality Auditor (CQA) or similar professional certification is a plus.

Qualification

• Bachelor of Science in Chemistry
• Bachelor of Technology in Computer Science
• Bachelor of Technology in Mechanical Engineering
• Bachelor of Business Administration
• Bachelor of Computer Applications

Experience

• A graduate degree from a reputed university. 3 - 16 years of overall CSV, QA, automation testing, or laboratory experience. Hands-on experience with 21 CFR/CSV regulations.
• Quality Assurance & Testing (3+ years)

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