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Apotex

Project Leader, Investigations

Toronto, ON, Canada
North York, ON, M9L 1T9, Canada

$73,008 to $121,680 CAD / year

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Job details

Pay: $73,008 to $121,680 CAD / year
Experience: 5-7 years’ experience in a pharmaceutical or manufacturing industry, preferably in a Manufacturing, Engineering or QA/QC role.
Posting language: English
Posted: Sep 30, 2026

Original job description

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 independently ensuring root cause analysis is conducted on investigations for ApotexOral Solid Dose (OSD) in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented. Acts as quality technical resource and reviews all investigation reports for completeness and accuracy, and compliance.
Responsible for initiating, investigating and reporting on customer product quality complaints in compliance with all applicable regulations and guidelines. Responsible for receipt and triage of customer complaints.

Job Responsibilities

Conducts investigations for complex product failures for Production/Packaging deviation and/or Technical and Medical Complaint investigations for all areas in manufacturing/packaging at Signet site following existing procedures. Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions. Writes product failure investigation reports for approval by Department Manager or Quality, as required.
Notify appropriate Team Leaders of validation, raw material, stability & in-process failures and ensure investigations are initiated and completed as per existing procedure. Act as quality technical resource and provide support & guidance to groups within Operations.
Perform an initial triage for criticality and ensure critical investigations with potential market impact follow the internal escalation procedure.
Participate in the preparation of Presentation and Incident Response Committee Meeting materials.
Laise with Apotex affiliates and customers to provide appropriate notification of critical events and coordinate preliminary investigation and escalation activities.
Interface with customers to obtain required information for investigation and escalation of technical complaints
Prepares and issues customer complaint acknowledgement letters, sample return instructions, response letters and provides investigation report to customer as per quality agreement.
Conducts follow-up for receiving of complaint sample and performs cycle count on controlled substance complaint samples in compliance with the procedure.
Receive, distribute, log and coordinate receipt of all complaint samples
Independently book and facilitate meetings with multiple Subject Matter Experts (SME’s) as required.
Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Review all investigation reports for completeness and accuracy prior to approval by Department Manager or Quality, as required.
Conduct impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, ect) and prepare recommendations for Department Managers.
Review on-going progress on all open investigations with Production Investigations team and Area Managers.
Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.
Project manages the corrective and preventative actions and assists in both implementation and follow-up.
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
- Post Secondary degree in Engineering, Sciences or a related technical field preferred or equivalent combination of College diploma and experience in a manufacturing environment
Knowledge, Skills and Abilities
- Fluency in project management & Root Cause Corrective Action (RCCA) tools
- Superior organizational, interpersonal communication skills
- Ability to manage time effectively and posses good critical thinking and problem-solving skills
- Ability to work independently and manage multiple priorities in a fast-paced and changing environment
- Strong command of the English language, both written and verbal
- Knowledge of Good Manufacturing Practices (GMP)
- Proficiency with Microsoft Word, Excel, and SAP.
Experience
- 5-7 years’ experience in a pharmaceutical or manufacturing industry, preferably in a Manufacturing, Engineering or QA/QC role.

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.

The hiring range for this position is $73,008 - $121,680 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.

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More about this job

Responsibilities

The Project Leader is responsible for conducting root cause analysis on investigations for oral solid dose products and ensuring corrective and preventative actions are implemented. They also act as a quality technical resource, managing customer complaints and coordinating with various departments to ensure compliance with regulatory standards.

Requirements

Candidates should possess a post-secondary degree in Engineering, Sciences, or a related technical field, along with 5-7 years of experience in a pharmaceutical or manufacturing environment. Proficiency in project management tools, GMP, and SAP is required, alongside strong communication and analytical skills.

Skills

Root cause analysis
Project management
Quality assurance
Technical writing
GMP
SAP
Critical thinking
Problem-solving
Communication skills
Manufacturing processes
Regulatory compliance
Incident response
Data analysis
Interpersonal skills
Microsoft Word
Microsoft Excel

Benefits

Bonus programs
Comprehensive benefits
Pension plan
Learning and development opportunities

Visa sponsorship

Not detected in the job text

Keywords

Root cause analysis
Corrective and preventative actions
Pharmaceutical
Manufacturing
Quality assurance
GMP
SAP
Technical complaints
Regulatory compliance
Project management
Incident response
Validation
Raw material
Stability
Packaging
Engineering
Science
Quality control
Data analysis
Documentation
Business ethics
Safety
Environment
Triage
Subject matter experts

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