Lead Consultant

1 month ago

bangalore, India Genpact Full time

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.
 
Inviting applications for the role of Lead Consultant - Quality Assurance Specialist
We are seeking a talented and experienced Lead Consultant with expertise in Quality Assurance (QA) to join our team. In this role, you will lead QA initiatives, provide strategic guidance, and hands-on support to ensure the successful implementation and optimization of QA processes and methodologies for our clients.
Responsibilities
1. Independently review Good Practices (GxP) Document Deliverables as a Subject Matter Expert (SME), reviewing, and approving key documents such as User Requirements Specifications, Validation Plan, Risk Assessment, PQ Protocols/Reports, Validation Summary Report, and releasing systems into production.
2. Ensure GxP document deliverables are consistent and in compliance with corporate policies and procedures following Food and Drug Administration (FDA) regulations and facilitate a risk-based lifecycle approach form business process description through system retirement.
3. Apply Global GxP requirements as part of a pragmatic validation strategy for global systems.
4. Monitor, manage and revise as needed, the Global Quality Computerized System Standard
5. Establish and enhance the relationships between IT, and other Functional groups, through collaboration, respectful challenge, and ability to strongly support QA decisions
6. Develop and deliver CSV education and awareness materials, to enhance site level awareness of Data Integrity requirements, and associate accountabilities.
7. Participate, as needed, in QA related audits of computerized systems, both internal and external.
8. Work with Internal audit, external auditors, management, and staff to identify feasible resolutions to control gaps and opportunities for improvement.
9. Guide in System Validation of Software as a service (Saas) tools for Project-specific intended use, Data Integrity, Code of Federal Regulations (CFR) 21 Part 11 Compliance, Audit Preparation and Support, Data Migration, and Release and Change Management Process.
10. Investigate validation discrepancies, drive deviation management, and create best practices for system validation including Computer System Validation (CSV) training and workshops.
11. Serve as Computer System support SME in support of audits and regulatory inspections.
12. Manage computer system related incident management program, including intake, evaluation, triaging, query, assignment, investigation, corrective action and reporting.
13. Maintain and organize the incident management database, creating relevant tracking reports, cases statuses, dashboards, summaries, and executive reports.
14. Drive the planning, implementation, administration, and communication of data privacy across the org.
15. Establish and oversee SKSLI standards and practices for the collection, use, transfer, storage and deletion of personal information.
16. Support the compliance risk management efforts including gap assessments and corrective action plans.
Qualifications we seek in you
Minimum Qualifications / Skills
• Bachelor's degree in Computer Science, Engineering, or related field (Master's degree preferred).
• years of experience in software quality assurance, with a focus on leading QA projects and teams.
• Strong understanding of QA principles, methodologies, and best practices.
Preferred Qualifications/ Skills
• Excellent analytical and problem-solving skills, with a keen attention to detail.
• Strong communication and collaboration skills, with the ability to work effectively in a team environment.

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