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Auditor, Compliance Audits

Date: Jan 15, 2022

Location: Etobicoke, ON, CA, M9W 6Y3

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

This is a senior Quality Assurance role that is responsible for all audit related functions, including internal audits of all systems, processes, facilities and equipment with the potential to impact product safety, identity, strength or purity.  This also includes assisting during customer, corporate and regulatory inspections of Apotex, and assisting with customer GMP-related requests. This role is also responsible for the maintenance and updating the site master file.

 

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. Preparation of monthly audit related metrics.
  3. With management, provide logistics support during inspections of Apotex by regulatory agencies and customer. Follow up and compile information to support commitments made in the response to inspection reports.
  4. Maintenance of audit data and files for each specific audit.
  5. Preparation of audit trend reports.
  6. Prepare and maintain the site master file. Periodic updates as required.
  7. Responsible for suggesting/evaluating changes to the system, making changes to the system, working with departments outside QA to improve quality as related to the system, producing reports as required, and training personnel on the system.
  8. Assist with the preparation of customer questionnaires for existing and new customers and GMP site registration packages for global markets.
  9. Write, update and review proposed Standard Operating Procedures, as required.
  10. 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.
  11. 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 business needs.
  12. Provide Quality and compliance support to other departments as required.
  13. 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;
  14. Works as a member of a team to achieve all outcomes;
  15. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
  16. Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and
  17. 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:
    • General 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.
    • Excellent written and verbal English communication skills.
    • 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.
    • 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.
    • Training in GMP, GLP and GALP. Experience with international regulations (e.g. FDA, EU) is an asset
  • Experience:
    • At least 5 years experience in the pharmaceutical industry, in a QA or QC role.
    • Experience conducting GMP audits is a benefit.

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements.  Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada.  Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

 

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.