About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, creative 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
📌 Senior Executive (India)
🏢 Apotex
📍 India