16 Aug
|
Apotex
|
Bengaluru
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, cutting-edge 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.
- Review of the executed BPCR’s /GCR’s and Manufacturing related documentation support.
- To ensure manufacturing documents are issued/archived as per procedure in line with manufacturing activities.
- To monitor and ensure the Dispatch activities initiated after the Quality release.
- Equipment and area clearance certification for product changeover.
- SAP transactions.
- Review of Analytical Test Data Sheets & Tests Reports for finished products, Intermediates, impurity standards a
📌 Deputy Manager (Bengaluru)
🏢 Apotex
📍 Bengaluru