Head of Manufacturing Investigation Processes
4 weeks ago
About Apotex Inc.
Apotex Inc. is a globally recognized Canadian health organization dedicated to producing high-quality, affordable medications for patients worldwide. With a workforce of nearly 7,200 employees engaged in manufacturing, research and development, and commercial operations, Apotex ensures that its medicines are accessible in over 75 countries. The company focuses on the development and marketing of generic, biosimilar, and specialty products through vertical integration. For more information, please visit our website.
Job Overview
The role is pivotal in guaranteeing that all investigations within the Manufacturing and Production departments are executed efficiently and promptly. The incumbent will ensure adherence to established protocols for all investigations and that corrective and preventive measures are effectively implemented.
Key Responsibilities
- Ensure that all manufacturing investigations are conducted and documented in 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 thorough impact assessments in collaboration with all relevant SMEs, including vendors.
- Determine the most likely root causes and corresponding corrective and preventive actions for all concluded investigations.
- Regularly monitor the progress of ongoing investigations with the Production Investigations team, Quality Assurance approvers, and Production Management to ensure timelines are met.
- Escalate any obstacles or issues that may jeopardize the timely completion of investigations.
- Prepare comprehensive, accurate, and concise investigation reports, ensuring they are complete and precise before submission for approval by the Department Manager.
- Lead or participate in cross-functional initiatives 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 effectively within a team to achieve all objectives.
- Adhere to our Code of Conduct and Business Ethics, as well as all established regulatory, compliance, and safety standards.
- Perform all tasks in alignment with our core Values: Collaboration, Courage, Perseverance, and Passion.
- Maintain a safe working environment while working collaboratively to achieve desired outcomes.
- Exhibit behaviors that reflect our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure compliance with all relevant programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- Undertake 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; exceptional organizational and interpersonal communication skills; ability to manage time effectively; capability 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 role.
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.
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