EY Business Consulting_Non FS Risk Transformation_Regulatory Compliance_Senior in Kolkata, India
Business ConsultingNon FS Risk TransformationRegulatory Compliance_Senior
Requisition # KKT0005N
Post Date Jan 09, 2021
EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior
As part of our EY-ER- 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, you’ll 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.
We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory 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.
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 Risk-Based 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,
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
To qualify for the role, you must have
B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies
Good interpersonal skills; Good written and presentational skills
Ideally, you’ll 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 fast-moving environment with consulting skills.
An opportunity to be a part of market-leading, multi-disciplinary 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, we’re dedicated to helping our clients, from start–ups 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 that’s right for you
As a global leader in Assurance, Tax, Strategy & transactions and Consulting services, we’re using the finance products, expertise and systems we’ve developed to build a better working world. That starts with a culture that believes in giving you the training, opportunities and creative freedom to make things better. Whenever you join, however long you stay, the exceptional EY experience lasts a lifetime. And with a commitment to hiring and developing the most passionate people, we’ll make our ambition to be the best employer by 2020 a reality.