Project Leader, Production Investigations

Job Summary

Responsible for independently ensuring root cause analysis is conducted on investigations for ApotexOral Solid Dose (OSD) in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented.  Acts as quality technical resource and reviews all investigation reports for completeness and acccuracy, and compliance.

Job Responsibilities

• Conducts investigations for complex product failures or deviation investigations for all areas in manufacturing/packaging at Signet site following existing procedures. Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions.  Writes product failure investigation reports for approval by Department Manager.
• Notify appropriate Team Leaders of validation, raw material, stability & in-process failures and ensure investigations are initiated and completed as per existing procedure. Act as quality technical resource and provide support & guidance to groups within Operations.
• Independently book and facilitate meetings with multiple Subject Matter Experts (SME’s) as required.
• Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Review all investigation reports for completeness and accuracy prior to approval by Department Manager.
• Conduct impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, ect) and prepare recommendations for Department Managers.
• Review on-going progress on all open investigations with Production Investigations team and Area Managers
• Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.
• Project manages the corrective and preventative actions and assists in both implementation and follow-up.
• Works as a member of a team to achieve all outcomes;
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and
• All other relevant duties as assigned

Job 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 & 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 (GMP)
  • 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