Project Leader, Complaint Inv-AGO-PIRH R

Job Summary

The Project Leader, Complaint Investigation is a member of the Production Investigaitons Team.  This role independently provides technical leadership, support and expertise - within the department, to other departments within the Apotex Group, and to customers related to Customer Compaints investigations. Represents Operations Investigations on teams and forums where GMP input is required.  The incumbent ensures that established procedures on how to report and investigate deviations and complaints are followed and appropriate corrective actions / preventive actions (CAPA) are identified and implemented.

Job Responsibilities

• Provide Product complaint history, upon request to internal customers.
• Coordinate complaint sample evaluations which require additional testing / examination by other departments/vendors
• Provide support to Complaints Coordinator as required to assist in complaint triage, creation, sample follow up attempts, and sample receipt.
• Investigate complaints to determine if attributable to internal or vendor related causes
• Responsible for escalation management of critical incidents related to customer complaints and drive the internal escalation process on behalf of the Site. Provide a high degree of project management to ensure that internal and external timelines are met. .
• Maintains current knowledge of regulatory requirements; reviews and revises processes to optimize compliance and efficiency
• Works as a member of a team to achieve all outcomes, including process improvements
• Provide training support in areas of Investigations and Complaints, within the department and to other groups as necessary.
• Provide support during regulatory or customer audits by presenting and explaining the investigations to the auditors.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Good Manufacturing Practices, Good Laboratory practices, Standard Operating Procedures, all regulatory requirements, Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor of Science Degree
  • Or College diploma in science, in conjunction with a minimum of 5 years relevant experience in the pharmaceutical industry
• Knowledge, Skills and Abilities
  • Detailed understanding in a wide variety of technical areas of pharmaceutical manufacture, testing, facilities and quality systems
  • Strong innovative skills and solid technical knowledge to effectively perform adequate investigations
  • Strong organizational, interpersonal and communication (oral and written) skills
  • Customer-service oriented
• Experience
  • 5-7 years’ experience in a pharmaceutical or manufacturing industry, preferably in a Manufacturing, Engineering or QA/QC role