QA Associate II at Teva Pharmaceutical Industries Ltd. - Israel

Toronto, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

27 Dec, 25

Salary

0.0

Posted On

28 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Change Control, Documentation, Quality Control, Quality Assurance, GMP, cGMP, SOPs, Analytical Skills, Problem Solving, Interpersonal Skills, Organizational Skills, Communication Skills, Impact Assessment, Investigations, Project Management, Regulatory Knowledge

Industry

Pharmaceutical Manufacturing

Description

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 QA Associate II supports change control management, review, and approval for Commercial quality related activities. This individual is responsible for processing and managing controlled documents that are under the scope of Commercial quality. The QA Associate II performs product launches and releases of imported products (Teva Affiliates and 3rd Party) to market and impact assessment with respect to the critical GMP issues. Reviews supplier documentation related to product launches and releases, validations, deviations, change controls, etc. The QA Associate II also conducts investigations related to deviations, OOS and OOT, and supports drug establishment licensing management, as required. The QA Associate II investigates Product Complaints and ensures the timely closure and approval of the records in QMS as required, and as needed to support with on-time launches of 3rd party product in coordination with internal and external groups. In addition, the QA Associate II supports with establishing systems and processes for Commercial Quality Canada to align with IM Commercial Quality.How you’ll spend your day Manages change control processes, reviews, and approves, for Commercial Quality related activities. Responsible for processing and managing controlled documents that are under the scope of Commercial Quality. Provides oversight of activities associated with imported products from Teva affiliates and 3rd Party and interacts with EMSO QA who manages 3rd party suppliers to ensure compliance with GMPs. Reviews and approves GMP documentation associated with Teva affiliates and 3rd Party supplied finished products including release documentation, deviations, validations, change records, etc. Supports completion of stability report updates for products imported from Teva affiliates. As required, supports with the drug establishment licensing management. Performs release of Teva affiliates and 3rd Party products to Canadian market. Liaises with Teva affiliates to ensure compliance with GMPs, adherence to Quality agreements and resolve quality issues. Ensures compliant, on-time launches of Teva affiliates and 3rd Party manufactured products in coordination with internal and external groups. Investigates, reviews and/or approves product complaints and ensures the timely closure of records in Harmony TrackWise. Performs comprehensive and detailed investigations for quality deviations (DRs) in a timely manner. Performs impact assessment for imported products towards Critical Incident Notification / Alerts. Performs Executed Batch Record Review for Teva affiliate products. Reviews internal procedures and Corporate Standards, performs gap assessments and updates SOPs accordingly. Supports with establishing systems and processes for Commercial Quality Canada to align with IM Commercial Quality. Supports other Compliance functions and projects as required. Supports inspections. Leads / manages special projects that require collaboration with cross-function teams and Teva Global Affiliates. Other related duties as required. Your experience and qualifications 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. Three (3) + years of relevant experience in Change Control, Documentation, Quality Control and/or Quality Assurance. Knowledge of Health Canada Regulation related to importation requirements. Experience in Word, Excel, QMS Preferred: Five (5) years of relevant experience in Quality Control, Quality Assurance or Operations or a proven track record within pharmaceutical industry Good working knowledge of SAP, QMS, Excel and Word. Must be proficient in MS word. Good knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Importation. Thorough understanding of manufacturing, packaging and laboratory operations. Advance writing skills: Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar. Planning/Organizational skills: Highly organizational skills used to set and manage priorities, handle multiple tasks in a timely manner, and ability to consistently evaluated work processes and outcomes Problem solving: Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions. Identifies and solves problems by gathering and applying information from a variety of sources. Must demonstrate ability to recognize critical situations and respond appropriately. Analyzes relationships among several parts of a problem or situation. Ability to anticipate obstacles and think of next steps. Recognizes multiple casual links: several causes of events, several consequences of actions, or multiple part chain of events. (A leads to B leads to C). Interpersonal skills: Educates internal and external customers on facts by taking into account differences in level of understanding, needs and expectations. Strong analytical, time management and organizational 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 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.

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Responsibilities

The QA Associate II manages change control processes and oversees activities related to the quality of imported products. They conduct investigations for deviations and product complaints, ensuring compliance with GMPs and timely product launches.