Job Summary

This is a senior Quality Assurance role that is responsible for the execution of internal audits performed for all areas, systems, processes and facilities governed by GMP as per the self-inspection audit schedule in accordance with site policies, procedures, current global regulations and Global Policies/Procedures.

The objective of the function is to identify through the examination and written evaluation that quality systems have been implemented, maintained and remain effective for the various processes/departments at Apotex.This position is also responsible for providing senior management with a clear understanding of the GMP compliance status of the areas audited and highlight any gaps identified during audits performed for GMP functions , with the potential to impact product safety, identity, strength, purity or quality.

Job Responsibilities

1. Perform internal audits, prepare reports and meet with department management to review report findings and, as necessary, assist in the investigation of internal audit findings to determine root cause and corrective action. Perform follow-up internal audits and issue follow-up reports. Coordinate and maintain an internal audit schedule.
2. Perform self-inspection audits of all systems and sub-systems as per the approved schedule, and perform ad-hoc/for-cause audits as required, to assess compliance with site policies/procedures, regulations and Global Policies and Procedures.
3. Document audit observations in a detailed written report and provide compliance assessment for the area/system/process audited. Perform a risk classification of all observations and communicate any critical or major observations to senior management.
4. Evaluate SME audit responses for observation(s) identified during self-inspections, Customer and Corporate audits to ensure each observation has been adequately addressed, and ensure that appropriate CAPAs are identified for remediation to prevent recurrence.
5. Conduct follow-up meetings with departments to ensure that self-inspection audit observations are being addressed and that the agreed corrective and preventative actions are completed on time.
6. Compilation and maintenance of self-inspection audit files and audit data.
7. Preparation of monthly audit metrics and yearly audit trend reports.
8. Assist Management, with inspection readiness activities and provide logistical support for Regulatory Inspections, Customer or Corporate audits. Review audit requests and provide coaching to SMEs. Follow up on commitments made in response to inspection findings, and compile information to be verified during subsequent audits by regulators/customers/corporate audit.
9. Review regulatory trends, global industry trends and affiliate compliance gaps as part of the internal audits performed as part of on-going surveillance to ensure sustainment of the compliance status.
10. Update and maintain Site Master Files (SMF) for the GTA sites.
11. Assist with the preparation of customer questionnaires for existing and new customers and GMP site registration packages for global markets.
12. Prepare/review and maintain Quality Assurance agreements (QAA) for Apotex affiliates and vendors used to provide GMP services at the GTA sites.
13. Write, update and review proposed Standard Operating Procedures, as required.
14. Ensure that all work is performed in full compliance with Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Procedures, all regulatory requirements, and established safety standards.
15. Work independently or in a team, either within QA or with various departments, to ensure that all work is completed in a timely fashion to meet the quality, compliance and business needs.
16. Acts as a designate to the manager for review/approval of risk assessment, audit plans and reports.
17. Provide Quality and Compliance support to other departments as required.
18. Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
19. Works as a member of a team to achieve all outcomes;
20. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
21. Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
22. All other relevant duties as assigned.

Job Requirements

Education: University life science degree (or an equivalent combination of post-secondary education and related work experience).

Knowledge, Skills and Abilities:

• Certifications: ASQ Certified Auditor; ISO Certified Auditor; Quality System certification training from a recognized institution (e.g., ASQ, NSF).
• Strong understanding of GMPs (US, Canadian, EU and others as required) as it relates to the assurance of quality in manufacturing, packaging, testing, storage and distribution of drug products.
• Possess fundamental understanding of manufacturing processes, validation disciplines, analytical methods and procedures.
• Excellent written and verbal English communication and technical writing skills to prepare accurate, comprehensive audit reports and metrics.
• Proven ability to work independently to effectively problem-solve and provide guidance.
• Superior interpersonal skills and ability to work effectively in a team environment within and outside the department with varied disciplines within the company and be able to clearly communicate, negotiate and resolve problems in a manner that meets the quality and compliance expectations.
• Ability to be flexible and manage multiple priorities in a fast-paced environment.

Experience:

• At least 8 years' experience in the pharmaceutical industry, in a QA or QC role with demonstrated Quality Assurance experience in auditing processes and Regulatory and Customer Inspections.
• Experience with Microsoft Computer Products (Word, Excel, Access, Project). Experience with SAP is an asset.

The hiring range for this position is $ 83126.43- $ 116,377.00 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.

We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.

The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex