Senior Officer-QA

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

Responsible for ensuring Stability related activites

Job Responsibilities

• Review & processing of Stability Study Initiation Request form.
• Review and approval of stability study protocol.
• Initiation of stability study change / termination forms.
• Review and approval of Stability study specifications (Stability Test Profiles) in LIMS.
• Review and approval of stability study final reports.
• Review of stability study schedule & Follow up for completion of the stability study as per the schedule.
• Review & approval of stability study analytical data in LIMS and approval of stability study data sheet (SSDS).
• Preparation of shelf life report and revision of shelf life certificates, through change controls process.
• Review and approval of stability chambers alarm trending reports.
• Handling of Change controls, Deviations and investigations related to the Stability study activities.
• Coordination with other departments for Stability / Shelf life related queries.
• Coordination and support for Business development support and regulatory affairs activities.
• Handling of Analytical Quality Assurance related activities
• Preparation of SOPs and forms related to analytical activities as and when required.
• Performing Change control impact assessment.
• Performing the LIMS, Track wise and SAP activities as per designated roles.
• Review / Approval of Laboratory Analytical Data for Reference standards, Raw material, Solvents, Operational supplies and D M Water.
• Review of E-Data and Audit trial records in the Empower and other standalone instruments and accordingly locking the empower channels and standalone instruments data as applicable.
• Review and approval of Laboratory 00S / OOTlQR / Lab event reports & Investigation reports in LIMS and Trackwise.
• Supporting Internal audits as SME for analytical functions and Performing un­ announced Realtime check as per the Schedule.
• To adhere the EHS policy & procedure in routine activities.
• To involve in EHS related activities on need basis
• All other relevant duties as assigned.
• All other relevant duties as assigned by supervisor

Job Requirements

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.

Skills Required

empower , Sap, Lims, Change Control