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Assistant Manager - Quality Control Testing
Apotex Inc.
Bengaluru, IND
Full-time
Senior · 9+ years experience
Onsite
Discovered 3 weeks ago
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Role Overview
The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments.
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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 Summary
The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments.
Job Responsibilities
- Preparation of Process validation protocol, Cleaning validation protocol and cleaning evaluation report, trending and establishment of LCL and UCL, APQRs and VMP supporting documents.
- Preparation of Trending reports (Raw materials, Intermediates and Finished API) as per the schedule.
- Re-evaluations, Temperature Mapping, Equipment change controls, DM water Validation, Environmental Monitoring, Calibration & Preventive Maintenance activities.
- Preparation, Review of protocols and reports for Equipment, Support system qualification.
- Execution and monitoring of Environmental monitoring Programs.
- Execution and monitoring of Temperature mapping study.
- Monitoring of Preventive Maintenance activities.
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