Analytical Quality Control Executive

Executive, Analytical QC-ARPL-NOS AR

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

Execution and reporting of Analytical Method verification/validation of Compendia, Site Transfer, Supplier Driven changes (SDC), Cleaning methods and Method Life Cycle Management (MLCM) studies.Preparation of Method validation/ verification protocols and reports.

Job Responsibilities

• Analysis of Compendia, SDC, MLCM and Cleaning Analytical methods verification/ validation / transfer studies by adhering to the regulatory procedures.
• Preparation of Method verification/ Method transfer Protocols and reports.
• Perform all work in accordance with all established regulatory compliance and safety requirements.
• Responsible for the activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality system.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. 
• All other relevant duties as assigned.

 

Job Requirements

Education

• MinimumMSc/BPharm or any equivalent degree.

Knowledge, Skills and Abilities

• Command on Microsoft-Office (Word, Excel).
• Able to prioritize the tasks.
• Best in effective completion of work activities to meet the time lines.
• Able to perform multi parameter analysis on HPLC instrument.

Experience:

• Minimum 3 to 6 years of experience in GMP regulated Pharmaceutical Industry.

 

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.

 

Experience Level

Executive Level