OT Quality Associate
Core
Ensure an audit-ready OT environment through development and maintenance of procedures, work instructions, and operational handbooks, while conducting quality reviews and supporting audits.
Role type
Senior OT Quality Associate (Pharma)
Builds
Operational handbooks, audit-ready procedures, CAPA/deviation management systems
Domain
Pharmaceutical manufacturing / Operational Technology (OT)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PLC, SCADA, automation, CSV, OT CSV, User Access reviews, Technical audit trail reviews (TATR), Incident reviews, CAPA management, SOP restructuring, Vendor onboarding, HSE, GxP, QA
Preferred skills
Project management, Supplier & Contract Management, Organizational development, Business Continuity, Cost Management, Operational Excellence, Problem Solving, Risk Management, Stakeholder Management, Vendor Management
Technologies
PLC, SCADA, Automation systems
Responsibilities
Manage user access reviews, user groups, technical audit trail reviews, and incident reviews; Support and follow-up of CAPAs and deviations; Verify and update OT procedures and create Automation Operational Handbooks; Manage exceptions, patching, and shared privileged accounts; Manage server licenses and certificates; Manage vendor onboarding and support; Support internal and external audits; Lead or contribute to improvement projects for equipment, utilities, and facilities; Select suppliers and establish contracts, SLAs, and MSCs.
Seniority
Senior, hands-on IC
