Coordinator, Sterile Validation

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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Job Summary

The Coordinator, Sterile Validation is responsible for all sterile validation activities at the Apotex Richmond Hill site. The incumbent will work cross-functionally with Engineering, Production and Quality in the execution of validation and re-validation of sterilization processes (i.e. thermal validation, VHP validation), air flow visualization studies, and aseptic process simulations (APS).

Job Responsibilities

• Ensure all sterile validation activities are performed in compliance with corporate policies, FDA, HPFBI, EC, and ICH’s guidelines including but not limited to the following: Thermal (Moist / Dry Heat) and Gaseous (VHP / ETO) Validation Irradiation (Gamma / E-Beam) of Primary Packaging Components Container Closure Integrity Sterilizing Filter Validation Airflow Visualization Studies (Smoke Studies) Filter Validation Studies
• Generate and coordinate the execution of all sterile validation protocols.
• Complete summary reports for Sterilization Validation
• Assess impact of proposed changes to validated production equipment / production processes, evaluate and execute requalification and revalidation when there is significant change in either product or its manufacturing process and for ongoing validation maintenance.
• Preparation of Sterilization Process Validation and other reports for regulatory submissions, including, responses to deficiencies, comparability protocols, new submissions and supplements.
• Operate and maintain equipment/instruments.
• Assist in the calibration of equipment/instruments as required.
• Initiate change controls and update SOPs in the area of expertise.
• Communicate with suppliers to obtain required technical information.
• Provide technical guidance and subject matter expertise to sterile operations and investigations.
• Review validation documentation for compliance with cGMP and SOPs.
• 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
• Minimum B.Sc in Biology / Microbiology / Applied Pharmaceutical Sciences, Engineering or related discipline.
• Knowledge, Skills and Abilities
• Proficiency in Written and Verbal English communication.
• Knowledge of Excel, Word, other Microsoft office programs, and validation software

packages would be an asset.

• Experience Minimum 3-5 years of experience in a GMP production environment, sterile manufacturing or validation experience is an asset.

At Apotex, we are committed to fostering a welcoming andaccessible 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.

The hiring range for this position is $65,790- $87,720 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.
We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.
The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.