Manufacturing Investigations Lead

1 week ago

Richmond Hill, Ontario, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a global pharmaceutical company that specializes in the development and production of high-quality, affordable medicines. With a strong presence in over 75 countries, Apotex employs a diverse 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 and production departments are conducted in a timely and efficient manner. This involves ensuring that established procedures are followed and that corrective and preventative actions are implemented to prevent future occurrences.

Key Responsibilities

  • Conduct thorough investigations into manufacturing deviations and document findings in accordance with site procedures and Good Manufacturing Practices (GMPs).
  • Identify critical paths for investigations and implement timely corrective and preventative actions.
  • Facilitate meetings with subject matter experts and vendors as required.
  • Perform thorough impact analysis in collaboration with subject matter experts and vendors.
  • Ensure the identification of root cause, corrective action, and preventative action for all completed investigations.
  • Regularly review progress on open investigations with the production investigations team, QA approver team, and production management team to ensure timely completion.
  • Escalate any roadblocks or issues that may impact investigation timelines.
  • Prepare clear, accurate, and concise investigation reports and review reports for completeness and accuracy prior to approval.
  • Lead, oversee, or participate in cross-functional projects associated with manufacturing deviation reduction initiatives.
  • Assist production supervisors and team leaders in ensuring investigations are initiated and relevant information is gathered in a timely manner.
  • Provide technical support and guidance to teams within operations.
  • Work collaboratively with teams to achieve outcomes.
  • Operate in accordance with Apotex's Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
  • Perform all work in support of Apotex's values: Collaboration, Courage, Perseverance, and Passion.
  • Work safely and collaboratively as a team member to achieve outcomes.
  • Demonstrate behaviors that exhibit Apotex's organizational values.
  • Ensure personal adherence to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • Perform other relevant duties as assigned.

Requirements

  • Education: Post-secondary degree in Engineering, Sciences, or a related technical field preferred or equivalent combination of college diploma and experience in a manufacturing environment.
  • Knowledge, Skills, and Abilities:
    • Fluency in project management and Root Cause Corrective Action (RCCA) tools.
    • Superior organizational, interpersonal communication skills.
    • Ability to manage time effectively.
    • Ability to work independently and manage multiple priorities in a fast-paced and changing environment.
    • Strong command of the English language, both written and verbal.
    • Knowledge of Good Manufacturing Practices (GMPs).
    • Proficiency with Microsoft Word, Excel, and SAP.
  • Experience: 5-7 years' experience in a pharmaceutical or manufacturing industry, preferably in a manufacturing, engineering, or QA/QC role.

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