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Specialist, Investigations QA - Brantford

Date: Feb 10, 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

Participates in activities to develop, execute and maintain effective quality incident management program and ensures Compliance, to corporate and global drug regulatory agency requirements.  Contributes to the site investigation certification program.  Drives cross-functional investigation teams to collaborate in timely investigation, risk control, continuous improvement and effectiveness checks. Responsible for supporting Quality Culture through investigation, execution and monitoring for effectiveness.  Ensures that work complies with health and safety standards, SOPs, cGMP and regulatory requirements.

Job Responsibilities

  • Reviews and approves investigations and makes recommendations for continuous improvement.
  • Coordinates activities to address noted deficiencies, and contributes to the development of corrective action plans and responses. Monitors the implementation of CAPAs.
  • Proactively schedule and leads meetings with cross functional personnel and/or management to resolve investigations and/or CAPA planning
  • Participates in investigations for Product Complaint system may include registering the complaint and performing internal notification, performing activity related to investigations, identifying appropriate corrective action and preventative action plans, authoring/approving reports, customer communication/notification and monitoring status until complaint closure.
  • Performs queries and trend analysis to generate requested reports. Communicates/presents to management, stakeholders or regulatory inspectors as required.
  • Participate as a trainer for the Investigator certification program or any other training requirements
  • May participate as a QA representative  in customer audits and/or regulatory body inspections.  
  • Schedules, assigns and prioritizes work to meet individual and departmental objectives
  • Works as a member of a team to achieve all outcomes.
  •  Perform all work in support of our Corporate Values of Passion, Perseverance, Collaboration and Courage; Demonstrates strong and visible support of our values.
  • Perform all work in accordance with all established regulatory and compliance and safety requirements.
  • Writes, updates and reviews Standard Operating Procedures and risk assessment reports. Co-ordinates operational or systematic changes through Change Control. Approve/review Change controls, as designated.
  • Participates in customer and regulatory body inspections.  Contributes to responses, tracking and reporting commitment status.
  • 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

  • Education
    • Education at the University level in a related scientific discipline.
  • Knowledge, Skills and Abilities
    • Strong practical knowledge of pharmacopoeial requirements and other related regulatory guidelines.
    • Detail-oriented with strong analytical, investigative and technical report-writing skills.
    • Strong technical knowledge and practical skills in critical/analytical thinking and investigation requirements
    • Effective communication (verbal and written) skills.
    • Demonstrated effective project coordination/management and leadership skills.
    • Good knowledge of statistical data analysis.
    • Strong proficiency in computer applications and programs such as Word, Excel and Project Management related software.
    • Good understanding of API manufacturing environment.
  • Experience
    • Laboratory analysis experience required. Current instrument qualification and/or investigation experience preferred.
    • Minimum of five years Pharmaceutical Industry experience within Analytical laboratory, Manufacturing environment and/or Quality Assurance
    • Proven experience in effective critical thinking techniques covering documentation, system operations, and operational activities in pharmaceutical environment.
    • Strong practical experience in interpretation and application of cGMP pharmaceutical regulations and guidelines (Canada, USA, ICH), with focus on quality systems.
    • Experience in maintaining complete and accurate documentation/records/data, filed in an organized, secure and easily retrievable manner.

 

 

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.