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Manufacturing Investigations Supervisor
3 months ago
About Apotex Inc.
Apotex Inc. is a globally recognized Canadian health organization dedicated to producing high-quality, affordable pharmaceuticals for patients worldwide. With a workforce of nearly 7,200 individuals across manufacturing, research and development, and commercial sectors, Apotex ensures that its medicines are accessible in over 75 countries. The company emphasizes vertical integration, focusing on the development and distribution of generic, biosimilar, and specialty products.
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Job Overview
The role is pivotal in guaranteeing that all investigations within the Manufacturing and Production divisions are conducted efficiently and within set timelines. The individual will ensure adherence to established protocols for all inquiries and that corrective and preventive measures are effectively implemented.
Key Responsibilities
- Ensure all manufacturing-related investigations are thoroughly examined and documented, maintaining compliance with site protocols and applicable Good Manufacturing Practices (GMP).
- Identify critical paths for investigations to facilitate timely root cause analysis and the implementation of corrective and preventive actions.
- Organize and lead meetings with various Subject Matter Experts (SMEs) as necessary.
- Conduct comprehensive impact assessments in collaboration with all relevant SMEs, including external vendors.
- Accurately determine the most likely root causes, corrective actions, and preventive measures for all completed investigations.
- Regularly monitor the progress of ongoing investigations with the Production Investigations team, Quality Assurance approvers, and Production Management to ensure timelines are met.
- Report any obstacles or issues that may jeopardize the timely completion of investigations.
- Prepare detailed, precise, and concise investigation reports, ensuring they are complete and accurate before submission for approval by the Department Manager.
- Lead, oversee, or contribute to cross-functional projects aimed at reducing manufacturing deviations.
- Support Production Supervisors and Team Leaders in initiating investigations and gathering pertinent information regarding deviations promptly. Serve as a technical resource, providing guidance and support to operational teams.
- Collaborate as part of a team to achieve all objectives.
- Adhere to the company's Code of Conduct and Business Ethics, along with all regulatory, compliance, and safety standards.
- Conduct all work in alignment with our core Values: Collaboration, Courage, Perseverance, and Passion.
- Work safely and collaboratively to achieve desired outcomes.
- Exhibit behaviors that reflect our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure compliance with all programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- Perform any other relevant duties as assigned.
Qualifications
- Education: A post-secondary degree in Engineering, Sciences, or a related technical field is preferred, or an equivalent combination of a college diploma and experience in a manufacturing setting.
- Knowledge, Skills, and Abilities: Proficiency in project management and Root Cause Corrective Action (RCCA) tools; excellent organizational and interpersonal communication skills; ability to manage time effectively; capacity to work independently and juggle multiple priorities in a dynamic environment; strong command of the English language, both written and verbal; knowledge of Good Manufacturing Practices (GMP); proficiency in Microsoft Word, Excel, and SAP.
- Experience: 5-7 years of experience in the pharmaceutical or manufacturing industry, ideally in a Manufacturing, Engineering, or QA/QC capacity.
At Apotex, we are dedicated to creating an inclusive and accessible work environment where all employees feel valued, respected, and supported.
Apotex provides accommodations for applicants with disabilities as part of its recruitment process. If you are contacted to arrange an interview or testing, please inform us if you require any accommodations.
