Business Analyst

We are seeking a highly skilled Business Analyst with 1+ 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

• 1+ 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 Type: Full-time

Pay: ₹180,000.00 - ₹400,000.00 per year

Benefits:

• Flexible schedule
• Health insurance
• Paid sick time
• Paid time off
• Provident Fund
• Work from home

Ability to commute/relocate:

• Ekkattuthangal, Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

• Are you an Immediate Joiner? "_______"
• What is your current CTC? "_______"
• What is your expected CTC? "_______"

Location:

• Ekkattuthangal, Chennai, Tamil Nadu (Preferred)

Work Location: In person