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Manufacturing Investigations Lead
2 months ago
About Apotex Inc.
Apotex Inc. is a global pharmaceutical company that specializes in the development and production of high-quality, affordable medicines. With a presence in over 75 countries, Apotex employs a team of professionals in manufacturing, research and development, and commercial operations.
Job Summary
The Manufacturing Investigations Lead is responsible for ensuring that all investigations within the manufacturing department are conducted in a timely and efficient manner. This involves ensuring that established procedures are followed and that corrective and preventative actions are implemented.
Key Responsibilities
- Conduct thorough investigations into manufacturing deviations and ensure that root causes are identified and addressed.
- Collaborate with subject matter experts to identify critical paths and implement corrective actions.
- Facilitate meetings with cross-functional teams to ensure timely resolution of investigations.
- Perform impact analysis to identify potential risks and implement preventative measures.
- Ensure that investigation reports are accurate, complete, and compliant with regulatory requirements.
- Lead cross-functional projects to improve manufacturing deviation reduction initiatives.
- Provide technical support and guidance to production supervisors and team leaders.
- Work collaboratively with the production management team to ensure that investigations are initiated and resolved in a timely manner.
Requirements
- Post-secondary degree in engineering, sciences, or a related technical field.
- 5-7 years of experience in a pharmaceutical or manufacturing industry, preferably in a manufacturing, engineering, or QA/QC role.
- Fluency in project management and root cause corrective action tools.
- Superior organizational, interpersonal, and 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.