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Assistant Manager – Quality Control Testing
Apotex Inc.Quality Control Testing Assistant Manager role at Apotex focused on validation protocols and quality control responsibilities in pharmaceutical manufacturing.
About the role
Key responsibilities & impact- Preparation of Process validation protocol
- Cleaning validation protocol and cleaning evaluation report
- Preparation of Trending reports (Raw materials, Intermediates and Finished API)
- Re-evaluations, Temperature Mapping, Equipment change controls, DM water Validation, Environmental Monitoring
- Preparation, Review of protocols and reports for Equipment, Support system qualification
- Execution and monitoring of Environmental monitoring Programs
- Review of the executed BPCR’s /GCR’s and Manufacturing related documentation support
Requirements
What you’ll need- M.Sc. / M. Pharma
- To Follow cGMP
- Knowledge on ICH Q7
- Experience in regulatory inspection like USFDA, TGA MHRA etc
Benefits
Comp & perks- Accommodation for applicants with disabilities as part of the recruitment process
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Process ValidationCleaning ValidationTrending Report PreparationTemperature MappingEquipment Change ControlDM Water ValidationEnvironmental MonitoringProtocol ReviewManufacturing Documentation Support
Certifications
M.Sc.M. Pharma