Assistant Manager Quality Control Testing
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Job Summary
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.
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The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments.
- 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 BPCRs /GCRs 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 and reference standards.
- Preparation of certificate of analysis for impurity standards and reference standards.
- Retain samples maintenance.
- Quality Control Laboratory rounds for monitoring online GLP compliance.
- IPQA Activities in Manufacturing & Packing
- Education:
- . / M. Pharma
- Knowledge Skills and Abilities:
- To Follow cGMP Knowledge on ICH Q7 Experience in regulatory inspection like USFDA TGA MHRA etc
- Experience:
- 9 to 12 Years
At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
Required Experience:
Manager
About Company
Apotex is the largest Canadian-owned pharmaceutical company providing patients around the globe with quality, affordable medicines. We are an innovative global research and technology leader in generic pharmaceuticals that serves customers and partners in the U.S. market, as well as 1 ... View more
