25 ene
Ernst & Young Advisory Services Sdn Bhd
Ciudad de México
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Date: Jan 10, 2025
Requisition ID: 1504134
EY - GDS Consulting - Enterprise Risk (ER) - Regulatory Compliance - Senior
As part of our EY-ER- Regulatory Compliance team, you will help clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior, you will 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 the EY senior management team,
and lead internal initiatives.
The opportunity
We’re looking for a 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 while being instrumental in the growth of emerging service offerings.
Your key responsibilities
- Actively contribute to the IT applications project management initiatives that include 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 are in line with the 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, adapt methods & practices to fit operational team needs & contribute to thought leadership documents.
- Demonstrate teamwork 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 client's 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.
- Train and mentor project resources.
- Cross-skill and cross-train team members as per business requirements.
Skills and attributes for success
- Prior experience of leading quality and compliance projects in Regulatory Compliance.
- Sound domain knowledge in the pharmaceutical industry in the areas of Quality Management System - 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 organizations.
- 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, Data Migration strategy and report, 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, oral, and presentation skills.
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