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Engaged Employer

Ernst & Young

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3.5

based on 10.1k Reviews

2045 Ernst & Young Jobs

RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior

Ernst Young

3.5

based on 10.1k Reviews

5-8 years

Bangalore / Bengaluru

1 vacancy

RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior

Ernst & Young

posted 11hr ago

Job Role Insights

Flexible timing

Key skills for the job

SAP CO Quality Assurance Project Management Risk Management Information Security Change Management

+ 3 more

Job Description

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 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,

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

Employment Type: Full Time, Permanent

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What people at Ernst & Young are saying

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Flexible timing

Monday to Friday

No travel

Day Shift

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