Role & responsibilities
- 8 to 12+ years of CSV / CSA / Quality Technology experience
- Strong Pharmaceutical, Biotech, or CDMO experience
- Experience supporting GxP-regulated manufacturing environments
- Understanding of Manufacturing, Quality, Laboratory and Supply Chain processes
- Prior experience interacting directly with Quality/QA organizations

CSV / CSA Leadership
- Hands-on Computer System Validation (CSV) experience
- Strong understanding and practical implementation of Computer Software Assurance (CSA)
- Ability to establish risk-based validation/assurance strategies
- Experience leading validation for implementations, upgrades, migrations and major changes
- Ability to lead multiple validation workstreams and oversee junior CSV/CSA resources

3. Regulatory & Compliance

Solid working knowledge of:
- FDA 21 CFR Part 11
- EU GMP Annex 11
- GAMP 5
- FDA CSA guidance/principles
- Data Integrity / ALCOA+
- GxP requirements and regulated SDLC

4. Validation Deliverables

Hands-on experience developing/reviewing:
- Validation / CSA Plans
- GxP Impact Assessments




- System Risk Assessments
- URS
- IQ/OQ/PQ and/or CSA-based testing
- Requirements Traceability Matrix
- Part 11 / Annex 11 Assessments
- Deviations / Exceptions
- Validation Summary Reports
- Change Control / Validation Impact Assessments

5. GxP Technology Experience

Strong validation experience with at least 23 of the following:
- MES
- LIMS
- QMS / eQMS
- ERP – SAP, D365 or Oracle
- Laboratory systems/instruments
- Manufacturing systems
- Veeva or other regulated SaaS applications

6. Leadership & Stakeholder Management
- Ability to work directly with Customer Quality, IT, Manufacturing and Business leadership
- Strong customer-facing communication
- Ability to challenge and influence stakeholders on validation strategy
- Ability to coordinate vendors, implementation partners and internal teams
- Experience supporting audits and regulatory/customer inspections
- Ability to operate as the CSV/CSA

📌 Hiring CSV (Mumbai)
🏢 Hexaware Technologies
📍 Mumbai