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Project Leader, Change Control Management

APOTEX

This is a Contract position in Etobicoke, ON posted May 5, 2022.

 

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

 

Responsible for ensuring change controls are reviewed and assessed in a timely and efficient manner.  Able to independently evaluate change controls with sufficient information to correctly-determine the appropriate change path for evaluation and execution.  Acts as a technical resource and coach for the business units to ensure awareness of the impact of a change.

 

**This is a 1-year contract, eligible for benefits**

Job Responsibilities

 

  • Assesses Change Control Record (CCR) documentation for accuracy and compliance to SODs and GMP.
  • Assesses impact of change (departments, other documents, markets, master data, etc.) and ensures all aspects of the change have been considered.
  • Reviews details of change to determine if the change concurs with the proposed strategies, and ensures change owner has assigned appropriate implementation tasks and order of execution.
  • Review the assessments provided by the impacted Functional Department / Area to determine if a formal risk assessment is required and if the appropriate actions have been identified to mitigate all potential risks
  • Works with change owner as applicable to ensure execution of the implementation plan.
  • Signs off as QA Responsible to execute change.
  • Can correctly assess the appropriate change path by considering compliance implications.
  • Schedule and send out agenda for Etobicoke Change Review Board meetings.
  • Facilitate cross-functional discussions ensuring all items on the agenda have been discussed.
  • Effectively define meeting objective and bring the attendees back to the project scope if off-track.
  • Provide a clear verbal summary of next steps if required at the close of the meeting.
  • Provides coaching and feedback to the business to raise awareness of the change impact.
  • Track and communicate performance metrics/scorecard to the site
  • Performs all duties and responsibilities in accordance with established GMP/cGMP operating procedures and safety standards.
  • Assists in responding to customer requests for information as routed to the site through External Manufacturing Quality.
  • Is cross-trained in other areas of quality review and approvals, such as Validation reports, Deviations and Annual Product Reviews.
  • 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.
  • 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
    • Minimum Bachelor of Science degree or equivalent in a related discipline, or equivalent experience.
  • Knowledge, Skills and Abilities
    • Breadth of experience in Validation, Quality or Production such that the individual can assess impact of changes across all functional areas.
    • Extensive knowledge of GMP
    • Demonstrated-ability to work independently and effectively-manage multiple priorities in a fast-paced and changing environment.
    • Ability to apply risk-based decision-making in ambiguous or unprecedented circumstances.
    • Excellent English oral and written communications.
    • Excellent interpersonal skills.
    • Strong customer-service orientation.
    • Intermediate to advanced skills in MS Excel, Word, Access and Microsoft Project
  • Experience
    • Minimum 5-7 years experience in the Pharmaceutical industry in the areas of Quality or Production.

 

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.