Apotex Inc.
Website:
apotex.com
Job details:
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com .
Job Responsibilities
Technology Transfer & New Product Introduction
Support product technology transfer and commercialization activities.
Prepare and review MFRs, risk assessments, PPQ, CPV, and validation documents.
Support site transfer, product launch, and manufacturing readiness activities.
Monitor optimization, demonstration, validation, and commercial batches.
Product Lifecycle Management (PLCM)
Execute technical assessments throughout product lifecycle.
Prepare technical summary reports, investigation reports, and PLCM forms.
Support process optimization and manufacturing efficiency initiatives.
Assess product and process changes for quality and compliance impact.
Perform process, quality, CPV, and APQR data trending.
Manufacturing Process Support
Provide shop-floor technical support for commercial products.
Troubleshoot manufacturing and process-related issues.
Investigate process deviations and atypical results.
Support root cause analysis and CAPA implementation.
Drive resolution of technical issues.
QMS & Compliance
Support deviations, investigations, CAPA, and change controls.
Participate in risk assessments and effectiveness checks.
Act as SME for product and process investigations.
Prepare scientific justifications and technical assessments.
Maintain compliance with GMP, SOPs, and Data Integrity requirements.
Support TrackWise activities and documentation.
Data Trending & Continuous Verification
Perform trending of manufacturing, validation, and quality data.
Support Continued Process Verification (CPV) activities.
Identify adverse trends and recommend improvements.
Support APQR/PQR preparation and review.
Supplier Driven Changes (SDC)
Evaluate alternate API and excipient suppliers.
Prepare material assessment reports and risk evaluations.
Assess quality and manufacturing impact of supplier changes.
Support implementation of approved supplier-driven changes.
Documentation & Regulatory Support
Prepare and review protocols, reports, SOPs, and technical documents.
Maintain GMP-compliant documentation.
Support internal audits, self-inspections, and regulatory inspections.
Support regulatory submissions and responses.
Cross Functional Collaboration
Coordinate with Manufacturing, QA, QC, Engineering, Packaging, Warehouse, Regulatory Affairs, and Supply Chain.
Support product launches, validation programs, and remediation projects.
Participate in continuous improvement initiatives.
Execute additional MS&T activities assigned by management.
Education
M.Pharm (Pharmaceutics or Quality Assurance)
Certification in Validation, Risk Management, Quality Systems, or Six Sigma is desirable.
Experience
5 to 7 years of experience in a GMP-regulated pharmaceutical industry.
Hands-on shop-floor exposure in oral solid dosage manufacturing.
Experience in Technology Transfer, PLCM, Process Validation, CPV,
Experience in QMS activities including Deviations, CAPA, Investigations, and Change Controls.
Knowledge & Skills
Experience with TrackWise or equivalent electronic quality systems preferred.
Strong knowledge of oral solid dosage manufacturing.
Understanding of GMP, ICH guidelines, QRM and validation requirements.
Knowledge of USFDA, Health Canada, and EMA regulatory requirements.
Strong technical writing, problem-solving, and communication skills.
Proficiency in MS Office and data analysis tools.
At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
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