Shop-Floor QA SME
Toronto, ONUnited Pharma
Mandatory requirements; Experience with batch record review, line clearance and in-process QA checks; Strong working knowledge of good documentation practice and data integrity on the floor
Validation & Quality Engineering SME
Toronto, ONUnited Pharma
5+ YOECandidates need at least five years in pharmaceutical cleaning validation and five years in validation or quality engineering. They also need knowledge of IQ/OQ/PQ, change control, ICH Q9 risk management and cross-contamination control in multi-product facilities.
Data Integrity SME
Toronto, ONUnited Pharma
5+ YOEUnited Pharma needs candidates with 5+ years in GMP data integrity assessments and remediation, hands-on audit-trail experience on systems like Empower, Chromeleon, LIMS, or SCADA/HMI, and working knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+, and MHRA/PIC/S/FDA guidance.
Empower, Chromeleon, LIMS, SCADA/HMI