Business Consulting_Non FS Risk Transformation_Regulatory Compliance

Job Description

EY- GDS Consulting Enterprise Risk (ER) Regulatory Compliance Staff 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 staff actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you ll consistently provide high quality deliverables, achieve operational efficiency proactively identify and raise risks with the client as well as EY senior management team and participate in internal initiatives.The opportunity We re looking for Staff with expertise in Computer System Validation for Pharma and Medical Devices to join the 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.
• Assist Seniors, 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.
• Actively contribute to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
• Foster teamwork and a positive learning culture
• Understand and follow workplace policies and procedures
• Participate in the organization-wide people initiatives
• Get cross skilled and cross trained as per the business requirements

Skills and attributes for success

• Quality & Compliance managed services and Consulting experience in of Life Sciences Domain.
• 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 on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
• Basic knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
• Basic knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
• Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts.
• Basic Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization.
• Versed with SOP documentation, analysing the work instructions, user manuals
• Hands on experience of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems
• Basic understanding of Data Integrity requirements
• Basic Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
• Experience in supporting Audits / Inspections would be add-on

To qualify for the role, you must have

• B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Post graduate in Science (Preferably in Chemistry/Bio-Chemistry) with 3-5 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)
• 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

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Keyskills :
business process transformationenvironmental impact assessmentcomputer system validationsoftware quality assuranceit risk21 cfrstatements of work sow