CSV/Computer system validation-Senior

The opportunity

Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team.

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.
• 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 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
• 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.
• 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,
• 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

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

Ideally, you'll also have

• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
• Information Security or Risk Management certifications