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RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior
5-8 years
Bangalore / Bengaluru
1 vacancy
RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior
Ernst & Young
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
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
Read full job descriptionPrepare for Compliance roles with real interview advice
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Flexible timing
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Ernst & Young Bangalore / Bengaluru Office Locations
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Ernst & Young, 3rd Floor, Tower C, RMZ Infinity Municipal No. 3, Survey No 1477/2 & 10, Old Madras Road, Benniganahalli, K.R. Puram
Bangalore
Karnataka 560016
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Bengaluru Office
Ernst & Young
Tower C, 3rd Floor, RMZ Infinity
Municipal No. 3, Old Madras Road
Survey No 1477/2 & 10
Benniganahalli, K.R. Puram
560016 Bengaluru
Ernst & Young
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12th & 13th Floor
No. 24, Vittal Mallya Road
Bengaluru
Bengaluru
560001
560001
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