RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior-BLR HYD CCU MAA COK-L

At EY youll have the chance to build a career as unique as you are with the global scale support inclusive culture and technology to become the best version of you. And were counting on your unique voice and perspective to help EY become even better too. Join us and build an exceptional experience for yourself and a better working world for all.

EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Senior
As part of our EYER Regulatory Compliance team you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish maintain and strengthen internal and external relationships. In line with our commitment to quality youll consistently drive projects to completion with high quality deliverables achieve operational efficiency proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our EYRegulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

• Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
• Integrate technology with business process transformation programs like SAP LIMS ELN MES Documentum TrackWise Veeva Vault ValGenesis Argus Regulatory Information Management System etc.
• Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions.
• Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
• Perform Software classification IT risk assessment and Mitigation strategies for IT applications.
• Provide guidance and share knowledge and participate in performing procedures focusing on complex or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
• Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
• Create innovative insights for clients adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
• Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
• Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the clients business.
• Review status updates and prepare management presentations.
• Actively contribute to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends competitor activities EY products and service lines.
• Contribute to performance feedback for staff
• Foster teamwork and a positive learning culture
• Understand and follow workplace policies and procedures
• Training and mentoring of project resources
• Cross skill and cross train the team members as per the business requirements

Skills and attributes for success

• Prior experience of leading quality and compliance projects in Regulatory Compliance.
• Good understanding of regulations such as USFDA WHO HIPAA TGA MCC Anvisa etc.
• Well versed with ICH guidelines ISPE framework on Risk management and SDLC
• Strong Knowledge on Enterprise IT applications like LIMS SAP ELN MES Documentum TrackWise Veeva Vault ValGenesis Argus Regulatory Information Management System etc. in Pharmaceutical organization
• Proficient in SOP documentation drafting work instructions/user manuals authoring and review of Validation Deliverables such as Validation Plan & report Requirement specifications Risk Analysis Qualification Protocols & reports Test Scripts Traceability Matrix etc.
• Demonstrated track record in project management governance and reporting
• Good understanding of Quality System Elements such as Deviation CAPA and Change Controls etc.
• Exposure to Data Integrity requirements and other applicable regulations
• Knowledge of Incident Management Change Management Periodic Review Vendor Management Quality Management Review procedures
• Prior experience of supporting Audits / Inspections
• Sound domain knowledge in Pharmaceutical industry in the areas of Quality control Quality assurance
• Strong knowledge of Computerized Systems validation concepts such as GAMP 5 A RiskBased Approach to Compliant GxP Computerized Systems
• Hands on experience of preparing validation deliverables for software implementation projects
• Sound understanding of standards such as USFDA 21 CFR Part 11 EU GMP Annex 11

To qualify for the role you must have

• B.E/ (Electronics Electronics & Telecommunications Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 58 years of experience with Big 4 or MultiNational Regulatory Compliance companies
• Good interpersonal skills; Good written and presentational skills

Ideally youll also have

• Certified Software Quality Engineer (CSQE) Certified Software Quality Assurance (CSQA)
• ISO 9001:2015 Lead Auditor Quality Auditor Certification (CQA)
• Information Security or Risk Management certifications

What we look for

• A Team of people with commercial acumen technical experience and enthusiasm to learn new things in this fastmoving environment with consulting skills.
• An opportunity to be a part of marketleading multidisciplinary team of 1400 professionals in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY were dedicated to helping our clients from startups to Fortune 500 companies and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus we offer:

• Support coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way thats right for you

EY Building a better working world

EY exists to build a better working world helping to create longterm value for clients people and society and build trust in the capital markets.

Enabled by data and technology diverse EY teams in over 150 countries provide trust through assurance and help clients grow transform and operate.

Working across assurance consulting law strategy tax and transactions EY teams ask better questions to find new answers for the complex issues facing our world today.