IT/OT Qualification Lead | CSV & GMP Expert

Avacone; Indianapolis (IN); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Avacone is seeking a Qualification Lead to ensure IT/OT system qualification and quality management in GMP environments. You will author, review, and approve validation deliverables in line with Customer Quality Manual and regulatory requirements.

Lead project test resources, act as quality representative for testing activities, and engage with QA, IT/OT teams and suppliers to ensure compliant deliverables and successful FAT/SAT, commissioning, and startup activities.

Formación

• Experience with CSV/CQV validation in GMP environments.
• Strong understanding of regulatory expectations (EU GMP Annex 11, 21 CFR Part 11).
• Ability to author/review validation deliverables (URS, FS, IQ, OQ, PQ).
• Hands-on IQ/OQ/PQ execution and FAT/SAT support.

Responsabilidades

• Lead qualification and validation activities for IT/OT systems.
• Coordinate with QA, IT/OT, and suppliers to ensure compliant deliverables.
• Act as project quality representative for testing activities and status reporting.

Conocimientos

CSV/CQV experience

GMP manufacturing

Regulatory knowledge

Quality leadership

Herramientas

Kneat

ValGenesis

Veeva Vault

TrackWise

ServiceNow

Descripción del empleo

Avacone is seeking a Qualification Lead to ensure IT/OT system qualification and quality management in GMP environments. You will author, review, and approve validation deliverables in line with Customer Quality Manual and regulatory requirements.

Lead project test resources, act as quality representative for testing activities, and engage with QA, IT/OT teams and suppliers to ensure compliant deliverables and successful FAT/SAT, commissioning, and startup activities.