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Senior Manufacturing Investigations Lead
4 weeks ago
About Apotex Inc.
Apotex Inc. is a global health company that produces high-quality medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations.
Job Summary
The Senior Manufacturing Investigations Lead is responsible for ensuring timely and efficient completion of investigations within the Manufacturing and Production departments at the Richmond Hill site. This role ensures established procedures are followed, and corrective and preventative actions are implemented.
Key Responsibilities
- Investigate manufacturing deviations and document findings in compliance with site procedures and GMPs.
- Identify critical paths for investigations to ensure timely root cause analysis and corrective actions.
- Facilitate meetings with Subject Matter Experts (SMEs) as required.
- Perform thorough impact analysis with SMEs, including vendors.
- Ensure accurate identification of root cause, corrective action, and preventative action for completed investigations.
- Regularly review ongoing progress with the Production Investigations team, QA approver team, and Production Management team to ensure attainable timelines.
- Evaluate and escalate any roadblocks or issues that may impact investigation timelines.
- Prepare clear, concise investigation reports and review them for completeness and accuracy prior to approval.
- Lead cross-functional projects associated with manufacturing deviation reduction initiatives.
- Support Production Supervisors/Team Leaders in initiating investigations and gathering relevant information in a timely manner.
- Operate in accordance with Apotex's Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
Requirements
- Post-secondary degree in Engineering, Sciences, or a related technical field preferred or equivalent combination of College diploma and experience in a manufacturing environment.
- Fluency in project management and Root Cause Corrective Action (RCCA) tools.
- Superior organizational, interpersonal communication skills.
- Ability to manage time effectively and work independently in a fast-paced environment.
- Strong command of the English language, both written and verbal.
- Knowledge of Good Manufacturing Practices (GMP) and proficiency with Microsoft Word, Excel, and SAP.
- 5-7 years' experience in a pharmaceutical or manufacturing industry, preferably in a Manufacturing, Engineering, or QA/QC role.
Apotex is committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process.
