Senior Specialist, Quality Computer Validation (18 month contract)
Core
Lead and support computer system validation and qualification activities for GxP-regulated systems, software, and equipment to ensure compliance with quality management systems and regulatory expectations.
Role type
Senior Specialist, Quality Computer Validation (IC)
Builds
Validated computerized systems, software, and controlled-temperature environments for healthcare distribution and pharmaceutical operations.
Domain
Life Sciences / Pharmaceutical Distribution / GxP Compliance
Required skills
Computer system validation lifecycle management, IQ/OQ/PQ documentation, risk assessment, change control, CAPA, GAMP 5, EU GMP Annex 11, SAP ERP, regulatory inspection support
Preferred skills
Health Canada GMP requirements, temperature-controlled storage/transportation qualification, bilingual English/French communication
Technologies
SAP, GAMP 5, EU GMP Annex 11
Responsibilities
Lead or support computer system validation and qualification activities across the system lifecycle; Author, review and execute validation deliverables including plans, requirements, risk assessments, and test protocols; Prepare and execute IQ/OQ/PQ documentation; Assess change controls, deviations, investigations, and CAPA; Coordinate validation activities with cross-functional teams and external consultants; Mentor colleagues with less validation experience.
Seniority
Senior, hands-on IC