About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.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
At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
