Job Summary

The Senior Business Analyst at HCL will be responsible for data analysis, business analysis, and Agile methodology to support various projects and initiatives. The role involves interpreting and analyzing complex data sets, identifying trends, and providing valuable insights to drive business decisions. Additionally, the Senior Business Analyst will collaborate with cross functional teams to gather requirements, prioritize tasks, and ensure successful project delivery.

• Domain: Hands‑on with QMS processes (Change Control, Deviations, CAPA, Complaints, Audits/Inspections, Training).
• Platform: Working knowledge of Veeva Vault QMS configuration concepts (objects, lifecycles, workflows, roles, permissions), and awareness of release management (e.g., 24Rx cadence and regression considerations referenced in internal portfolio updates).
• Legacy Systems: Ability to reverse engineer data models and workflows from legacy tools and map them to Veeva constructs.
• Requirements & Process: Advanced elicitation, user story writing, acceptance criteria, non‑functional requirements for GxP (auditability, security, performance).
• Compliance/CSV: Familiarity with GxP, 21 CFR Part 11/Annex 11, risk‑based validation, and audit readiness
• Lead scoping workshops and define clear in‑scope/out‑of‑scope items.
• Gather, analyze, and document business and functional requirements (URS/FRD).
• Map as‑is legacy processes to Veeva Vault QMS and perform fit/gap analysis.
• Define and maintain QMS data elements, data dictionary, and reporting needs.
• Create process maps (as‑is/to‑be) and ensure GxP‑aligned workflows.
• Maintain RTM, support user stories, and assist with backlog refinement.
• Partner with QA/CSV for risk-based validation and audit‑ready documentation.
• Support UAT, configuration reviews, defect triage, and release readiness.
• Prepare training materials and support change management and adoption.
• Contribute to migration planning, data rules, and cutover readiness.
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Key Responsibilities

1. Conduct thorough data analysis to support strategic decision-making processes
2. Work closely with stakeholders to gather and document business requirements
3. Utilize agile methodology to facilitate project planning, execution, and delivery
4. Identify opportunities for process improvement and efficiency enhancements
5. Prepare and present reports and recommendations based on data analysis findings
6. Collaborate with it teams to ensure alignment between business objectives and technical solutions
7. Participate in user acceptance testing (uat) and provide support during implementation phase
8. Stay updated on industry best practices in data analysis, business analysis, and agile methodologies

Skill Requirements

• Domain: Hands‑on with QMS processes (Change Control, Deviations, CAPA, Complaints, Audits/Inspections, Training).
• Platform: Working knowledge of Veeva Vault QMS configuration concepts (objects, lifecycles, workflows, roles, permissions), and awareness of release management (e.g., 24Rx cadence and regression considerations referenced in internal portfolio updates).
• Legacy Systems: Ability to reverse engineer data models and workflows from legacy tools and map them to Veeva constructs.
• Requirements & Process: Advanced elicitation, user story writing, acceptance criteria, non‑functional requirements for GxP (auditability, security, performance).
• Compliance/CSV: Familiarity with GxP, 21 CFR Part 11/Annex 11, risk‑based validation, and audit readiness.

Other Requirements

1.Agile Certified Practitioner (ACP) or Certified Business Analysis Professional (CBAP) certification preferred