Senior Auditor - Quality Systems (pharma)

Date: May 19, 2019

Location: Richmond Hill, ON, CA, M9L 1T9

Company: Apotex

 

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary

Responsible for the development, implementation, maintenance and improvement of systems supporting the Corporate Quality Audit function.  Monitors adherence to the Quality Audit Schedule, updating and reporting metrics and trends.  Tracks execution of individual audits. Analyses data, identifies risk and escalates concerns appropriately.  Coordinates teams across boundaries.  Supports and contributes to the Corporate Quality as required.

 

 

Job Responsibilities

  1. Manages, develops, maintains, updates and publishes the Global Quality Audit Schedule in accordance with Apotex SOPs.
  2. Manages requests for Due Diligence visits/audits and ensures requests are appropriately supported along with the Global Quality Audit Schedule.
  3. Coordinates and assists, across boundaries, Managers, Senior Auditors and Auditors in the planning and allocation of supplier audits according to the Global Quality Audit Schedule, tracking and assuring adherence to the Schedule, and making efficient and effective use of resource.
  4. Manages the Global Audit Schedule of Apotex sites, liaising and facilitating the audit timings and arrangements as required.
  5. Tracks the execution of individual quality audits to assure compliance with Apotex SOPs and Regulator expectations.
  6. Tracks the closure of auditee CAPAs against the timelines agreed.

 

  1. Responsible for leading metrics collection and  measuring the performance of the Corporate Audit function and as a means of continuous improvement.  Metrics are reported on time in relevant monthly and periodic trend reports. 

 

  1. Analyses data from Corporate, Regulatory and Customer audits, trends observations and escalates as required.  Creates and disseminates ‘lessons learned’ and provides direction to Apotex functions, sites and suppliers, as areas of focus for training and improvement.

 

  1. Where relevant to maintain auditor accreditation, Perform GMP quality audits, due diligence and partner audits supporting business development and the internal Corporate Audit program.

 

  1. Responsible for suggesting/evaluating improvements to the audit system, making changes to the system, working with departments within and outside QA to improve quality as related to the system, and training personnel on the system.

 

  1. Works with the management to ensure the continuous development and improvement of Apotex and supplier audit programs and systems.

 

  1. Provide logistics support during inspections of Apotex sites by regulatory agencies and customers, and provision of audit reports across boundaries.  Follow up and compile information to support response and commitments made in the response to inspection reports.

 

  1. Prepare, update and review proposed changes to SOPs, as required.

 

  1. Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:
    • Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually,
    • Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,
    • Providing coaching, feedback and recognition.
  2. Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment)
  3.  Works as a member of a team to achieve all outcomes.
  4. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
  5. Performs all work in accordance with all established regulatory and compliance and safety requirements.
  6. All other duties as assigned.

 

Job Requirements

  • University degree in science or science-related field
  • Minimum 8 years of relevant experience in the GMP Regulated industry, 5 years of which has been spent in Quality Assurance
  • Has experience of performing GMP Quality audits
  • Thorough knowledge of industry software eg TrackWise, SAP etc.
  • Thorough knowledge of current good manufacturing regulations as applicable to the pharmaceutical industry (e.g., Health Canada, FDA, EU and other international regulations)
  • Have knowledge and understanding of the ICH guidance documents
  • Clear and concise written and verbal English communication
  • Strong analytical skills
  • Strong communication, interpersonal and organizational skills
  • Excellent knowledge of Word, Excel, Powerpoint and other Microsoft office programs

 

 

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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