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Quality Assurance Associate - 1 year contract

Date: Jan 15, 2022

Location: Toronto, Ontario, CA, M1B2K9

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

The Quality Assurance Associate will provide support to operations by providing oversight to activities associated with the manufacturing and packaging of bulk and finished products by third party suppliers to ensure compliance with GMPs. Review and approve supplier documentation related to product release, validation, deviation, change controls, etc. Perform release of third party products to market. Perform impact assessment with respect to the critical GMP issues.
 

The QA Associate will Provide oversight of activities associated with the manufacture & packaging of bulk & finished products by 3rd party suppliers to ensure compliance with GMPs.

 

Tasks and responsibilities will include but are not limited to:

  • Review & approve GMP documentation associated with 3rd party supplied bulk & finished products including release documentation, deviations, validations, change controls, etc.
  • Liaise with 3rd party suppliers to ensure compliance with GMPs, adherence to Quality agreements & to resolve quality issues
  • Ensure compliant, on-time launches of 3rd party product in coordination with internal & external groups
  • Investigate Product Complaints and ensure the timely closure of the records in Harmony Trackwise
  • Perform comprehensive and detailed investigations for quality deviations (DR’s) related to 3rd party products in a timely manner
  • Provide metrics to Teva Global / Track KPIs for overdue deviations, CAPAs, batch release cycle time, etc;
  • Generate / trend monthly and quarterly reports;
  • Follow up and facilitate the completion of change controls, DRs, CAPAs and CAPAERs in a timely manner
  • Request stability data from the suppliers and perform stability review for all the third party products;
  • Draft / revise, negotiate and execute Quality Agreements with manufacturing sites, contract packagers, contract laboratories, etc.
  • Perform impact assessment for third party products towards Critical Incident Notification / Alerts
  • Perform Executed Batch Record Review for third party products
  • Review internal procedures and Corporate Standards, perform gap assessment and update SOPs accordingly
  • Perform retain sampling activities: conduct the receipt of retain samples, updating of Oracle / storage of retain samples and destruction of expired retain samples as per procedures
  • Support other Compliance functions and projects as required
  • Lead / Manage special projects that require collaboration with cross-functional teams and Teva Global Affiliates
  • Hazard Recognition and Investigation Skills: Identify, prevent, and proactively correct workplace hazards and conditions. Perform incident/accident investigations, root cause analysis, and establish appropriate corrective actions.
  • Role Modeling: Role modelling of EHS practices to prevent the release of materials/energy, reduce  EHS impacts, and ensure adherence to EHS regulatory requirements and procedures

Qualifications

 

  • University Degree in Science or related discipline from a recognized Canadian University (or non-
    Canadian institution evaluated as Canadian equivalent)
  • Must have a minimum of 1 (one) year relevant experience in Quality Control, Quality Assurance
  • 3 (three) + years relevant experience in Quality Control, Quality Assurance or a proven track record within pharmaceuticals is preferred.
  • Knowledge of USP, BP, EP compendia methods as well as ability to read and interpret house methods

Function

Quality

Sub Function

Quality Assurance Methods

Reports To

Sr Manager, Quality

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.