Teva Canada

Quality Assurance Associate

CA-ON-Toronto
2 months ago
Job ID
17-19314
# Positions
1
Category
Quality - Quality Assurance

Overview

Quality Assurance Associates x 3

Mississauga and/or Toronto, ON

 

At Teva Canada, we believe that all Canadians deserve access to innovative and affordable medications. We develop, produce and market generic pharmaceuticals, from diabetic agents to antibiotics, from heart medications to cancer treatments. We’ve been part of Canadian healthcare since 1965, when we began operations as one of the country’s first generic pharmaceutical companies. Today, we employ over 1,500 Canadians. We invest in facilities in this country—creating generic and brand-name medications. And we’re proud to be part of Teva Pharmaceutical Industries Ltd. Worldwide, Teva is the leader in generics, one of the top 10 pharmaceutical companies, active in 60 countries and a workplace of choice for 46,000 dedicated employees.

 

We are motivated by a passion to make a difference.

 

www.tevamakesmedicines.ca | www.tevacanadainnovation.com | www.tevapharm.com | www.tevacanada.com

 

Think You Know Teva Video:  https://www.youtube.com/watch?v=_onneAgyDNI

We Make the Difference Video:  https://www.youtube.com/watch?v=PGmabmbqhsw

 

Responsibilities

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.

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

  • Review & approve GMP documentation associated with 3rd party supplied bulk & finished products including release documentation, deviations, validations, change controls, etc.
  • Perform release of 3rd party products to market
  • 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
  • Thorough understanding of manufacturing, packaging and laboratory operations
  • Good working knowledge of Oracle, LIMS, Trackwise, Excel and Word
  • Functional:
  • Good working knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Manufacturing

Qualifications

Education Required:

University Degree / Science related discipline

 

Experience Required:

Knowledge of USP, BP, EP compendia methods as well as ability to read and interpret house methods

 

Experience Preferred:

3 years relevant experience in Quality Control, Quality Assurance, Product Development or Production or proven track record within pharmaceutical or related industry

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