*This is an 18 month contract opportunity*
Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals, who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our growing team.
This is a senior Quality Assurance role that is responsible for performing internal audits of all areas, systems, processes and facilities governed by GMP as per the internal audit schedule in accordance with site policies, procedures, regulations and Global Policies/Procedures.
The objective of this 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.
Other responsibilities include assisting during customer, corporate and regulatory inspections of Apotex, and assisting with customer GMP-related requests.
1. Perform internal audits of all areas identified in the internal audit schedule, and ad-hoc/for-cause audits as required, to assess compliance with site policies/procedures, regulations and Global Policies and Procedures.
2. 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.
3. Conduct follow-up meetings with departments to ensure that internal audit observations are being addressed and that the agreed corrective and preventative actions are completed on time.
4. Maintenance of audit data and files for internal audits performed.
5. With Site QA Audit Management, assist and provide support during Regulatory, Corporate or Customer inspections.
6. 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.
7. 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.
8. Provide quality and compliance support to other departments as required.
9. Perform other duties as required.
- University life science degree (or an equivalent combination of post-secondary education and related work experience).
- At least 5 years’ experience in the pharmaceutical industry, in a QA or QC role with demonstrated Quality Assurance experience in auditing processes.
- Certifications: AQQ Certified Auditor; ISO Certified Auditor; Quality System certification training from a recognized institution (e.g., 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.
- Proven ability 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 communicate negotiate and resolve problems in a manner that meets the quality and compliance expectations.
- Ability to manage multiple priorities in a fast-paced environment.
- Experience with Microsoft Computer Products (Word, Excel, Access, Project).
- Experience with SAP is 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.