TRD QA Specialist
Core
Provide QA oversight and support for establishing a compliant quality system for GMP-relevant IT, OT, computerized, and automated systems during pilot plant ramp-up and operationalization.
Role type
QA Specialist (GMP IT/OT Systems)
Builds
Compliant, validated computerized systems for manufacturing, QC laboratories, facilities, utilities, and supply-chain processes.
Domain
Pharmaceutical manufacturing / GxP Compliance / IT & OT
Required skills
Computerized-system validation and qualification, IT/OT quality and eCompliance, Operational Technology and industrial automation, Data integrity, electronic records, and electronic signatures, GxP documentation and procedure management, System lifecycle and periodic review management, Change, deviation, and CAPA management, Audit and Health Authority inspection support, Quality Management Systems
Preferred skills
Familiarity with EU GMP Annex 11, 21 CFR Part 11, GAMP 5, and data-integrity guidance, Experience with electronic Quality Systems for change controls and deviations, Ability to understand system architecture and data flows
Technologies
GMP-relevant IT/OT systems, Computerized systems, Manufacturing automation systems, Electronic Quality Systems
Responsibilities
Review and approve key validation and qualification deliverables, Ensure global applications and locally configured systems are assessed and released before GMP use, Ensure implementation and QA oversight of controls related to user access, audit trails, and data integrity, Review and approve changes, deviations, CAPAs, and risk assessments, Coordinate and support periodic reviews to confirm system compliance, Support internal audits and Health Authority inspections, Contribute to continuous improvement initiatives for validation activities
Seniority
Mid-level, hands-on IC