Project Leader, Production Investigations

Apotex Inc.; Richmond Hill; On-site; CAD 72,000 - 101,000; Full time

Benefits offered by this job

Disability accommodation

Comprehensive benefits

Pension plan

Learning & development opportunities

Bonus programs

Job summary

Apotex Inc. is seeking a Project Leader for Production Investigations in Richmond Hill, Canada. The role ensures investigations in Manufacturing and Production are completed on time, with proper procedures followed and CAPA implemented.

You will coordinate cross-functional teams, manage root-cause analysis, and produce clear reports for Department Manager approval, while upholding GMP and company values. The position offers a comprehensive rewards package.

Qualifications

• 5-7 years’ experience in a pharmaceutical or manufacturing industry.
• Knowledge of GMP principles and compliance.
• Proficiency with Microsoft Word, Excel, and SAP.

Responsibilities

• Ensure all manufacturing investigations are investigated and documented to comply with GMP site procedures.
• Identify critical paths for investigations and drive root cause, corrective and preventive actions.
• Facilitate meetings with SMEs and coordinate input across functions.
• Perform thorough impact analyses with SMEs and vendors.
• Identify probable root causes and implement corrective and preventive actions.
• Review ongoing progress with Production Investigations, QA approvers and Production Management to meet timelines.
• Escalate roadblocks and produce clear investigation reports for approval.
• Lead or participate in cross-functional projects to reduce manufacturing deviations.
• Support Supervisors/Team Leaders with timely information gathering and cross-team guidance.
• Work in teams to achieve outcomes while adhering to Code of Conduct and safety rules.
• Demonstrate values of Collaboration, Courage, Perseverance and Passion.

Skills

RCCA tools

Project management

Communication skills

Time management

Independent work

English proficiency

Education

Engineering/Sciences degree

Tools

SAP

MS Word

Excel

Job description

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Project Leader, Production Investigations

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.

Responsible for ensuring all investigations within the Manufacturing and Production departments at Richmond Hill site are completed in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented.

Job Responsibilities

• Responsible to ensure all manufacturing investigations are investigated and documented in a manner which ensures compliance with site procedures and all applicable GMP’s.
• Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions.
• Facilitate meetings with multiple Subject Matter Experts (SME’s) as required.
• Perform throrough impact analysis in collaboration with all SMEs including Vendors.
• Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations.
• Regularly review on-going progress on all open investigations with Production Investigations team, QA approver team and Production Management team to ensure all timelines are attainable.
• Escalate any roadblock/issues which may pose the risk for meeting the investigation timelines.
• Prepare clear, accurate and concise investigation reports and review the reports for completeness and accuracy prior to approval by Department Manager.
• Lead, oversee, or participate in cross functional projects associated with manufacturing deviation reduction initiatives.
• Assist Production Supervisors/Team Leaders in ensuring investigations are initiated and relevant information pertaining to the deviations are gathered in a timely manner. Act as technical resource and provide support & guidance to groups within Operations.
• Work as members of a team to achieve all outcomes;
• Operate in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Perform all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• 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
  • 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 everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of the recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require accommodation.

The hiring range for this position is 72,284.85 CAD to 101,198.79 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.