Katalyst CRO
CVS Lead at Katalyst CRO
The CVS Lead is responsible for leading Computer System Validation activities for GxP-regulated systems to ensure compliance with global regulatory standards. The role involves managing validation lifecycle activities, coordinating with cross‑functional teams, and ensuring audit readiness.
Key Responsibilities
Lead Computer System Validation (CSV) activities across multiple GxP systems
Own and manage CSV lifecycle (Plan, Requirements, Risk Assessment, IQ, OQ, PQ)
Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5
Review and approve validation deliverables
Validation Plans (VP)
User Requirement Specifications (URS)
Functional & Design Specifications (FS/DS)
Risk Assessments
Test Scripts & Traceability Matrix
Provide CSV governance for
ERP (SAP)
LIMS, MES, QMS
Laboratory instruments & interfaces
Lead and support regulatory audits & inspections (FDA, EMA, MHRA)
Manage change control, deviation, CAPA related to validated systems
Mentor and guide CSV analysts and validation teams
Coordinate with IT, QA, vendors, and business stakeholders
Drive data integrity (ALCOA+) compliance
Ensure periodic reviews and system retirement activities
Education & Experience
Bachelor's/Master's in Engineering, Computer Science, Pharmacy, or Life Sciences
8+ years of experience in Computer System Validation
Strong knowledge of
GxP regulations
GAMP 5
SDLC & Agile validation
Risk-based validation approaches
Hands‑on experience with validation of cloud‑based systems
Excellent documentation and audit handling skills
Strong leadership and stakeholder management abilities
Preferred Skills
Experience with SAP S/4HANA validation
Exposure to Agile / DevOps CSV
Knowledge of Data Integrity & Cybersecurity
Certification in CSV / GMP / Quality Systems
Tools & Technologies
SAP, LIMS, MES, TrackWise, Veeva, LabWare
JIRA, Confluence
Validation tools (Client ALM, qTest)
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function & Industries
Other
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
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Key Responsibilities
Lead Computer System Validation (CSV) activities across multiple GxP systems
Own and manage CSV lifecycle (Plan, Requirements, Risk Assessment, IQ, OQ, PQ)
Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5
Review and approve validation deliverables
Validation Plans (VP)
User Requirement Specifications (URS)
Functional & Design Specifications (FS/DS)
Risk Assessments
Test Scripts & Traceability Matrix
Provide CSV governance for
ERP (SAP)
LIMS, MES, QMS
Laboratory instruments & interfaces
Lead and support regulatory audits & inspections (FDA, EMA, MHRA)
Manage change control, deviation, CAPA related to validated systems
Mentor and guide CSV analysts and validation teams
Coordinate with IT, QA, vendors, and business stakeholders
Drive data integrity (ALCOA+) compliance
Ensure periodic reviews and system retirement activities
Education & Experience
Bachelor's/Master's in Engineering, Computer Science, Pharmacy, or Life Sciences
8+ years of experience in Computer System Validation
Strong knowledge of
GxP regulations
GAMP 5
SDLC & Agile validation
Risk-based validation approaches
Hands‑on experience with validation of cloud‑based systems
Excellent documentation and audit handling skills
Strong leadership and stakeholder management abilities
Preferred Skills
Experience with SAP S/4HANA validation
Exposure to Agile / DevOps CSV
Knowledge of Data Integrity & Cybersecurity
Certification in CSV / GMP / Quality Systems
Tools & Technologies
SAP, LIMS, MES, TrackWise, Veeva, LabWare
JIRA, Confluence
Validation tools (Client ALM, qTest)
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function & Industries
Other
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
#J-18808-Ljbffr