Quality Investigations Leader

Date: Apr 26, 2019

Location: Richmond Hill, ON, CA, L4C 5H2

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

The Project Leader, Investigations is a member of the Quality Operations Team.  This role independently provides technical leadership, support and expertise - within the department, to other departments within the Apotex Group, and to customers - concerning issues for which Quality Operations is responsible.  Represents Quality on teams and forums where GMP input is required.  The incumbent ensures that established procedures on how to report and investigate deviations and complaints are followed and appropriate corrective actions / preventive actions (CAPA) are identified and implemented.

Job Responsibilities

QA Approvals for Deviations and Complaints:

  • Oversees and acts as Quality Approver and SME for Apotex OLD Investigations at a site level and ensures investigations are initiated following existing procedure(s).
  • Acts as resource providing support and guidance to ensure quality investigation reports including investigation reviews and approvals in QMS Trackwise and submission of extensions.
  • Drive for root cause determination with a strong investigation plan, using root cause analysis tools, to assess impact and establish corrective & preventive actions, with effectiveness checks
  • Interact with Planning and Scheduling groups to prioritize approval of deviation investigations to meet  batch disposition/release timelines.
  • Provide Product complaint history, upon request to internal customers.
  • Coordinate complaint sample evaluations which require additional testing / examination by other departments/vendors
  • Provide support to Complaints Coordinator as required to assist in complaint triage, creation, sample follow up attempts, and sample receipt.
  • Investigate complaints to determine if attributable to internal causes
  • Participate in critical investigations (including stability OOS) and escalations to Management and Corporate Compliance. Provide support to Global Field & Market Response for issuance of FAR and recall activities as required.
  • Maintains current knowledge of regulatory requirements; reviews and revises processes to optimize compliance and efficiency
  • Works as a member of a team to achieve all outcomes, including process improvements
  • Provide training support in areas of Investigations and Complaints, within the department and to other groups as necessary.
  • Provide support during regulatory or customer audits by presenting and explaining the investigations to the auditors.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence with all compliance programs including the Good Manufacturing Practices, Good Laboratory practices, Standard Operating Procedures, all regulatory requirements, Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. 
  • All other relevant duties as assigned.

Job Requirements

  • Education
    • Bachelor of Science Degree
    • College diploma in science, in conjunction with a minimum of 5 years relevant experience in the pharmaceutical industry
  • Knowledge, Skills and Abilities
    • Detailed understanding in a wide variety of technical areas of pharmaceutical manufacture, testing, facilities and quality systems
    • Strong innovative skills and solid technical knowledge to effectively perform, review and approve adequate investigations
    • Strong organizational, interpersonal and communication (oral and written) skills
    • Customer-service oriented
    • Proven ability to lead and engage team members
  • Experience
    • Minimum 3-5 years of quality assurance experience in the pharmaceutical industry
    • Experience in Deviation and CAPA systems

 

 

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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