Hiring CSV / CSV Consultant

Job description

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