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Production Investigations Project Manager
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 employees engaged in manufacturing, research and development, and commercial operations, Apotex ensures that its medicines are accessible in over 75 countries. The company emphasizes vertical integration to focus on the development and distribution of generic, biosimilar, and specialty products.
For further details, please visit our website.
Job Overview
The role involves overseeing the completion of all investigations within the Manufacturing and Production departments at the Richmond Hill site, ensuring they are conducted efficiently and within established timelines. The position requires adherence to established protocols for investigations and the implementation of corrective and preventative measures.
Key Responsibilities
- Ensure that all manufacturing investigations are thoroughly 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 establishment of corrective and preventative actions.
- Organize and lead meetings with various Subject Matter Experts (SMEs) as necessary.
- Conduct comprehensive impact analyses in collaboration with all relevant SMEs, including vendors.
- Ensure accurate identification of root causes, corrective actions, and preventative measures for all completed investigations.
- Regularly monitor the progress of ongoing investigations with the Production Investigations team, QA approvers, and Production Management to maintain achievable timelines.
- Address any obstacles or issues that may hinder the timely completion of investigations.
- Prepare clear, precise, and comprehensive investigation reports, ensuring they are complete and accurate before submission for Department Manager approval.
- Lead or participate in cross-functional projects aimed at reducing manufacturing deviations.
- Support Production Supervisors and Team Leaders in initiating investigations and gathering pertinent information related to deviations promptly.
- Collaborate effectively as part of a team to achieve desired outcomes.
- Adhere to the company's Code of Conduct and Business Ethics, along with all regulatory, compliance, and safety standards.
- Perform all duties in alignment with our core Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure a safe working environment by collaborating with team members to achieve all objectives.
- Exhibit behaviors that reflect our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Maintain compliance with all programs, including the Global Business Ethics and Compliance Program, Global Quality policies, 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 handle multiple priorities in a dynamic environment; strong command of the English language, both written and verbal; familiarity with 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 throughout the recruitment process. If you are contacted to arrange an interview or testing, please inform us if you require any accommodations.
