Hiring CSV / CSV Consultant

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

Strong 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 SME and accountable validation lead

7. Global Delivery

• Experience working with global Life Sciences organizations
• Ability to support US and Germany/EU time zones
• Comfortable coordinating distributed teams and critical releases/cutovers

All Hexaware Locations.

Only Immediate Joiners