Jobs for People with MS: National MS Society

Quality Assurance Associate - 12 month contract

Date: Jun 14, 2024

Location:

Toronto, Canada, Ontario, M1B2K9

Company: Teva Pharmaceuticals

Job Id: 56579

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

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 Teva affiliates and 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.

How you’ll spend your day

• Provide oversight of activities associated with the manufacture & packaging finished products by Teva affiliates and interact with EMSO QA who manages 3rd party suppliers to ensure compliance with GMPs.

• Review & approve GMP documentation associated with Teva affiliates and 3rd party supplied finished products including release documentation, deviations, validations, change controls, etc.

• Perform release of Teva affiliates and 3rd party products to market.

• Liaise with Teva affiliates suppliers to ensure compliance with GMPs, adherence to Quality agreements & to resolve quality issues.

• Ensure compliant, on-time launches of Teva affiliates 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) in a timely manner.

• Perform impact assessment for third party products towards Critical Incident Notification / Alerts.

• 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.

• Draft / revise, negotiate and execute Quality Agreements with manufacturing sites, contract packagers, contract laboratories, etc.

• Perform Executed Batch Record Review for Teva affiliate 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 SAP / 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.

• Other duties as assigned

Your experience and qualifications

• One (1) to two (2) year’s relevant experience in Quality Control, Quality Assurance or Operations. Knowledge of USP, BP, EP compendia methods as well as ability to read and interpret house methods.

• Three (3) years relevant experience in Quality Control, Quality Assurance or Operations or a proven track record within pharmaceutical industry preferred

• Holds a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.

• Good working knowledge of SAP, LIMS, Trackwise, Excel and Word.

• Good working knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Manufacturing.

• Thorough understanding of manufacturing, packaging and laboratory operations.

• Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar.

• Highly organizational skills used to set and manage changing priorities, handle multiple tasks in a timely manner, and ability to consistently evaluate work processes and outcomes.

• Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions

• Interpersonal skills: Educates internal and external customers on facts by taking into account differences in level of understanding, needs, and expectations.

• Strong analytical skills.

• Excellent verbal and written communication skills.

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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

EOE including disability/veteran