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Ernst & Young (EY) Jobs – Biochemistry Candidates Apply
Ernst & Young (EY) Jobs – Biochemistry Candidates Apply. Ernst & Young Job Openings. Interested and eligible applicants can check out all of the details on the same below:
Name of the Post: Business Consulting_Non FS Risk Trsnasformation_Regulatory Compliance_Senior
Location: Bangalore, Karnataka, India
Req ID: BLR007HV
The opportunity:
We’re looking for Senior with expertise in Computer System Validation and also 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 add to the IT applications project management initiatives that include Validation activities as per the GAMP Life Cycle approach.
- Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, Track Wise, Veeva Vault, ValGenesis, Argus, Regulatory Info Management System etc.
- Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with pertinent functions.
- Perform Gap assessment as well as Remediation procedures for legacy applications to guarantee validation policies remains in line with Life Cycle Approach.
- Perform Software classification, IT risk assessment and also Mitigation strategies for IT applications.
- Provide guidance as well as share knowledge and also 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 as well as a strategy that complies with professional standards and addresses the risks inherent in the engagement.
- Aid Senior Managers in driving the business development procedure on existing client engagements by associating with clients as well as executing the deliverables in the most efficient manner.
- Create innovative insights for clients, adapts methods & practices to fit operational team requires & contributes to thought leadership documents.
- Demonstrate teamwork by working with cross-functional teams across service lines in completing the deliverables within the timelines.
- Maintain a solid client focus by effectively serving client needs as well as developing productive working relationships with client personnel. Stay abreast of current business as well as economic developments as well as brand-new pronouncements/standards relevant to the client’s business.
- Review status updates and also prepare management presentations.
- Proactively add to improving operational effectiveness on projects & internal initiatives.
- Demonstrate a comprehensive knowledge of market patterns, competitor activities, EY products and service lines.
- Add to performance feedback for staff.
- Foster teamwork as well as a positive learning culture.
- Understand and also adhere to workplace policies and also procedures.
- Training and mentoring of project resources.
- Cross skill and go across train the team members as per the business requirements.
Skills and attributes for success:
- Prior experience of leading quality and also compliance projects in Regulatory Compliance.
- Sound domain knowledge in the Pharmaceutical Industry in the areas of Quality control, Quality assurance.
- Solid 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 standards, ISPE framework on Risk management, and SDLC.
Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, Track Wise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization. - Proficient in SOP documentation, drafting work instructions/user manuals, authoring as well as a review of Validation Deliverables such as Validation Plan & report, Requirement specs, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
- Demonstrated track record in project management, governance, as well as reporting.
- Good understanding of Quality System Elements such as Deviation, CAPA, as well as 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 should have:
- B.E/ B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/ Postgraduate in Science (Ideally in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies.
Excellent interpersonal skills; Excellent written as well as presentational skills.
Ideally, you’ll likewise have:
- Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA).
- ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA).
- Info Security or Risk Management certifications.
What we look for:
- A Team of people with commercial acumen, technical experience and enthusiasm to learn brand-new things in this fast-moving environment with consulting abilities.
- An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated worldwide transaction business worldwide.
- Opportunities to work with EY Consulting practices around the world with leading businesses across a range of industries.
Click here to APPLY ONLINE
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