Gmp Root Cause Analysis Leader
Apotex Inc.
Apply GMP and RCCA expertise to manufacturing investigations at Apotex’s Richmond Hill facility. Produce clear reports and guide corrective action decisions.The Project Leader ensures investigations are completed efficiently and documented accurately for the Manufacturing and Production departments. You will determine probable root causes, coordinate reviews, and provide support to Operations. Success requires strong written and verbal English, independent prioritization, and regulatory compliance awareness.Key Responsibilities:
Determine probable root causes for completed manufacturing investigationsDefine corrective and preventative actions for investigation findingsReview reports for completeness and accuracy before approvalTrack progress with Production and Quality Assurance teamsMaintain compliance with quality, safety, and ethics requirementsRequirements:
Engineering, sciences, or related technical post-secondary degree preferredManufacturing, engineering, or QA/QC experience preferredFive to seven years in pharmaceutical or manufacturing industryFluency with project management and RCCA toolsStrong written and verbal English commandUse root cause analysis, GMP knowledge, and concise reporting to strengthen compliant investigations for Apotex operations.
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Determine probable root causes for completed manufacturing investigationsDefine corrective and preventative actions for investigation findingsReview reports for completeness and accuracy before approvalTrack progress with Production and Quality Assurance teamsMaintain compliance with quality, safety, and ethics requirementsRequirements:
Engineering, sciences, or related technical post-secondary degree preferredManufacturing, engineering, or QA/QC experience preferredFive to seven years in pharmaceutical or manufacturing industryFluency with project management and RCCA toolsStrong written and verbal English commandUse root cause analysis, GMP knowledge, and concise reporting to strengthen compliant investigations for Apotex operations.
#J-18808-Ljbffr
Vacancy posted 1 hour ago
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