Business Analyst

2 days ago

Chennai, Tamil Nadu, India Archimedis Digital Full time

Company Description

Archimedis Digital is a global professional IT services company that builds digital products and offers services exclusively to Life Sciences companies. We partner with clients to formulate and deliver growth across the digital life cycle. Leveraging our team's extensive Life Sciences knowledge and IT expertise, we tackle and solve complex cross-functional business challenges. Our offerings are crafted to make digital transformation a breeze.

We are seeking a highly skilled Business Analyst with 3+ years of experience in the Life Sciences (LS) domain to support requirement gathering, process analysis, solution design, and implementation of systems across GxP, R&D, Clinical, Regulatory, Quality, and Manufacturing functions. The ideal candidate will have strong analytical skills, hands-on experience with LS processes, and the ability to work closely with cross-functional teams to deliver compliant and efficient solutions.

Key Responsibilities

Business Analysis & Requirements:

  • Gather, analyse, and document business requirements (BRD, URS, FRS) for LS functions such as QA, QC, Manufacturing, Clinical, Regulatory, and R&D
  • Conduct stakeholder interviews, workshops, and process walkthroughs
  • Translate business needs into functional and non-functional requirements
  • Perform gap analysis, impact analysis, and feasibility studies

Process Mapping & Optimization:

  • Document current-state (As-Is) and future-state (To-Be) process flows
  • Identify process inefficiencies and recommend improvements aligned with LS best practices
  • Support digital transformation initiatives within GxP/Non-GxP environments

Solution Design & Implementation:

  • Collaborate with technical teams to design and configure solutions
  • Support system integration, data migration, and workflow enhancements
  • Review test scripts, perform UAT support, and ensure traceability

Compliance & Documentation:

  • Ensure deliverables meet GxP, CSV/CSA, 21 CFR Part 11, Annex 11, and other regulatory expectations
  • Prepare documentation: Requirements, Functional Specs, User Stories, Test Cases, SOPs, and Validation Documents

Stakeholder Management:

  • Act as a liaison between business stakeholders and technical teams
  • Facilitate discussions, resolve conflicts, and ensure requirements alignment
  • Provide regular project updates and maintain strong communication channels

Reporting & Insights:

  • Develop dashboards, reports, and analytics to support decision-making
  • Support KPI tracking and continuous improvement initiatives

Required Skills & Experience

  • 3+ years of proven experience as a Business Analyst in the Life Sciences/Pharma/Biotech domain
  • Strong understanding of LS processes: QA, QC, R&D, Manufacturing, Clinical, Regulatory
  • Knowledge of GxP, 21 CFR Part 11, CSV/CSA, SDLC, Agile methodologies
  • Experience with tools such as JIRA, Confluence, ALM, Veeva Vault, LIMS, TrackWise, SAP, or similar LS systems
  • Excellent documentation, analytical, and problem-solving skills
  • Strong communication and stakeholder management abilities
  • Ability to work independently and collaboratively in cross-functional teams

Preferred Qualifications

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or related field
  • Certifications in Business Analysis or Agile
  • Exposure to data analytics tools (Power BI, Tableau, Excel Advanced)

Job Location: Guindy, Chennai.

Salary: Commensurate with current experience.

Immediate Joiner preferred.

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