Complaints Project Leader

4 days ago

North York, Canada Apotex Inc. Full time

**About Apotex Inc.**

**Job Summary**:
This role is responsible for investigating and reporting on customer product quality complaints in compliance with all applicable regulations and guidelines. This role is responsible for receipt and triage of Customer complaints. 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 Complaints investigations. Represents Quality on teams and forums where GMP input is required.

**Responsibilities**:

- Investigate product quality related technical and medical complaints from customers and affiliates. Review data relevant to the complaint including batch records, product history, requests special testing, and examination of complaint and reserve samples. Prepare complaint investigation reports in Trackwise. Compile an appropriate written response to complainant (as required) justifying Apotex’s position.
- Receive and log Customer Complaints, perform an initial triage for criticality and ensure critical investigations with potential market impact follow the internal escalation procedure.
- Prepare and issue complaint acknowledgement letter and sample return instructions. Manage correspondence between the Customer and Apotex, as required.
- Receive, distribute, log and coordinate receipt of all complaint samples.
- Review and approve non-critical customer complaint investigations. Obtain information, analyses and prepare reports. Provide complaint history to assist internal investigations and recall.
- Prepare quarterly complaints trend reports, including data collection, treatment and analysis from SAP and Trackwise systems. Identify emerging trends and present appropriate actions in this report. Ensure the report is reviewed and approved by the deadline as per internal procedure.
- 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.
- Participate in the preparation of Presentations and Incident Response Committee Meeting materials.
- Liaise with Apotex Affiliates and customers to provide appropriate notification of critical events and coordinate preliminary investigations and escalation activities.
- Interface with customers to obtain required information for investigation and escalation of technical complaints.
- Provide input on the SOPs related to customer complaints to ensure they are in line with Quality Policy, and are updated as necessary.
- Perform self-evaluations and participate in annual performance appraisals. Co-manage own career development.
- Promote communication at all levels and strive to make all information available when and where needed. Build a network of technical support resources throughout the company
- Work as a member of a team to achieve all outcomes.
- Identify and implement improvements to Customer Complaint processes.
- Have good knowledge of the company product range history and detailed understanding of all Apotex documentation systems including Quality Policies, Master documents, SODs, Work Instructions and change control.
- Assist the group leaders in meeting departmental goals and objectives.
- Provide support during regulatory and customer audits. Present and explain the complaints systems to the auditors.
- Support our Values: Collaboration, Courage, Perseverance, and Passion.
- Perform all other relevant duties as assigned.

**Job Requirements**:

- Bachelor of Science
- 3-5 years of relevant working experience in a pharmaceutical environment.
- Must have a good overall understanding of pharmaceutical manufacturing processes.
- Experience performing investigations and/or similar responsibilities in Pharmaceutical Manufacturing operations and controls, Quality systems, APR and/or Validation.
- Excellent written and verbal English communication skills.
- Excellent customer service skills.
- Strong organizational skills and able to work with minimum supervision.
- Detail orientated and accurate.
- Ability to manage multiple priorities in a fast-paced environment.
- Experience with Microsoft Computer Products. SAP/MS Access knowledge an asset.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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.

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