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Specialist, Investigations Manufacturing Operations (Brantford)

Date: Sep 30, 2021

Location: Brantford, ON, CA, N3T 6B8

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

The Specialist, Investigations Manufacturing Operations will perform investigations and coordinate cross-functional investigations (Process, Production, Materials Management, Engineering/Maintenance, affiliated Sites, and third-party Liaison) to drive  timely assessment, risk control, documentation, effectiveness and continuous Improvement, role modeling an Excellence Culture and Company Values. The incumbent shall use leadership facilitation skills, technical expertise and strong technical writing skills to outline, develop, and execute the required actions and drive successful deviations resolutions. 

Deviation types the scope of this role may include to lead, but are not limited to:

  • GMP Batch Manufacturing Investigations
  • Overall Quality or Safety Related Critial Deviations and Incidents
  • Process execution, Technologies and Equipment Specific Incidents Investigations
  • Overall PR incident Support and Contnious Improvements Projects

Job Responsibilities

  • Manage local or cross functional projects/deviations to include:
    • Drive critical deviations, OOT, OOS for Manufacturing and Operations, through investigation and closure, primarily securing the True Root cause of the deviation and appropriate actions have been taken (CAPA). And safety, integrity, strength (potency), purity, and quality (SISPQ) of the product has been ensured.
    • Collaborating with Stakeholders, managers & resources across all areas to ensure a comprehensive, thorough science-based investigation is conducted.
    • Host specific meetings and coordinates items follow up and target completion dates. Involve managers and drive accountability for successful outcome.
    • Use Quality Tools and Problem-Solving methodologies (5W, Fishbone Diagram, Pareto, RCA HEART tool) to identify most effective corrective or preventative actions (SMART). Ensuring clear, concise science and evidence-based explanation and completion for on-time closure.
    • Reviews and approves investigations, deviations and CAPAs documentation to make sure is reliable, well organized, of high quality, generated in a timely manner, and comply with internal requirements and regulatory guidelines.
  • May conduct training, provide trending data and engage with regulatory, customer or internal audits preparation, during inspections and contributes to response activities.
  • Identify Opportunities for Improvements with the end goal of streamlining and prevent incidents.
  • 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 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

  • Post-secondary education in Pharmaceutical Technology, Chemical Engineering, Chemistry, or related science.
  • Excellent technical writing skills, communication, organisation, project management.
  • Scientific knowledge, critical thinking applied to investigations and risk assessment
  • cGMP’s, related regulatory guidelines, safety, and environmental regulations
  • Overall understanding of active pharmaceutical ingredients manufacturing.
  • Trackwise Investigation Certification and Training in lean manufacturing/continuous improvement is an asset.
  • Good knowledge of statistical data analysis, Word, Excel, PowerPoint and related software.
  • Minimum of 5 years of experience in chemical / pharmaceutical manufacturing environment.

 

 

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.