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 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 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.