QA Manager Documentation Review - Onsite Mississauga
Core
Lead QA teams responsible for GMP production documentation review, laboratory data review, and batch disposition to ensure compliance and data integrity.
Role type
Manager, Quality Assurance (Production Documentation & Lab Data Review)
Builds
Compliant pharmaceutical production batches and validated laboratory data
Domain
Pharmaceutical Development Services (PDS) and Commercial operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP documentation review, laboratory data review, batch disposition, team leadership, regulatory compliance (FDA/Health Canada/ICH/EMA), data integrity (ALCOA+), quality systems (deviations/CAPA/change control), trend analysis, electronic records management
Preferred skills
Six Sigma certification, knowledge of OOS/OOT investigations, experience with TrackWise/LIMS/Empower/SAP/MES
Technologies
TrackWise, LIMS, Empower, SAP, MES
Responsibilities
Lead and develop multiple documentation and lab data review teams; oversee timely review and approval of batch records and lab data; monitor performance metrics and review queues; support regulatory inspections and audits; develop procedures and training materials; escalate compliance risks
Seniority
Manager, hands-on leadership
