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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in process validation, cleaning validation, and environmental monitoring within a cGMP environment. Proficient in preparing and reviewing protocols and reports for equipment qualification and regulatory compliance.
Highest-signal resume keywords
Process Validation Protocol PreparationCleaning Validation Protocol PreparationEnvironmental Monitoring ExecutionRegulatory Inspection ExperienceKnowledge of ICH Q7
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Process ValidationCleaning ValidationTrending Report PreparationTemperature MappingEquipment Change ControlDM Water ValidationEnvironmental MonitoringProtocol ReviewManufacturing Documentation Support
Certifications & Qualifications
M.Sc.M. Pharma
Industry Keywords
CGMPUSFDATGAMHRA
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