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 flowsIdentify process inefficiencies and recommend improvements aligned with LS best practicesSupport digital transformation initiatives within GxP / Non-GxP environmentsSolution Design & Implementation :
Collaborate with technical teams to design and configure solutionsSupport system integration, data migration, and workflow enhancementsReview test scripts, perform UAT support, and ensure traceabilityCompliance & Documentation :
Ensure deliverables meet GxP, CSV / CSA, 21 CFR Part 11, Annex 11, and other regulatory expectationsPrepare documentation : Requirements, Functional Specs, User Stories, Test Cases, SOPs, and Validation DocumentsStakeholder Management :
Act as a liaison between business stakeholders and technical teamsFacilitate discussions, resolve conflicts, and ensure requirements alignmentProvide regular project updates and maintain strong communication channelsReporting & Insights :
Develop dashboards, reports, and analytics to support decision-makingSupport KPI tracking and continuous improvement initiativesRequired Skills & Experience
3+ years of proven experience as a Business Analyst in the Life Sciences / Pharma / Biotech domainStrong understanding of LS processes : QA, QC, R&D, Manufacturing, Clinical, RegulatoryKnowledge of GxP, 21 CFR Part 11, CSV / CSA, SDLC, Agile methodologiesExperience with tools such as JIRA, Confluence, ALM, Veeva Vault, LIMS, TrackWise, SAP, or similar LS systemsExcellent documentation, analytical, and problem-solving skillsStrong communication and stakeholder management abilitiesAbility to work independently and collaboratively in cross-functional teamsPreferred Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related fieldCertifications in Business Analysis or AgileExposure to data analytics tools (Power BI, Tableau, Excel Advanced)Job Location : Guindy, Chennai.
Salary : Commensurate with current experience.
Immediate Joiner preferred.