Job Description

Who are we?

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!



The Quality Assurance Specialist will coordinate DR investigations and ensure product impact is evaluated, root cause is determined and effective CAPAs are identified. Investigate all product quality complaints and provide customer responses. Perform trend analysis on quality deviations and complaints and evaluate CAPA effectiveness.

The specialist will also serve as a designate for review and approval of reports including but not limited to deviation and complaint investigations CAPA\'s and change control records.

Tasks and responsibilities will include but are not limited to:

• Lead and work collaboratively with cross functional departments, suppliers and customers to resolve quality deviations and complaints to determine root cause, evaluate product impact and identify applicable CAPAs to ensure compliance with GMPs and SOPs.
• Working with various cross functional departments and suppliers to support the completion of CAPAs and CAPAERs.
• Maintenance of local QTAs and QRMP program for the site.
• Evaluate excursions (e.g., environmental, temperature) for product impact. Perform evaluation and approval of change controls and recipes/validity rules approvals if applicable. Prepare a daily summary report for Complaints and DRs.
• Perform trend analysis for quality deviations and complaints.
• Support Quality audits by Regulatory authorities - Health Canada, US-FDA, etc. and Teva Global, as required and assist in coordination of actions as required.

Qualifications

• Must have a minimum 3 + relevant Quality Assurance experience in handling complex investigations using statistical tools
• Bachelors required
• 5 years relevant experience in Quality Control, Quality Assurance or Operations preferred or a proven track record within the pharmaceutical industry
• Must be computer literate with good working knowledge of TrackWise, Oracle, LIMS, Smart QA, MS Office suite (Excel and Word)
• Good working knowledge of SOPs, GMPs, and cGMP\'s applicable to Quality Operations, Manufacturing and Packaging
• This position requires a mechanical aptitude to understand manufacturing and packaging operations as well as the mechanical aspects of the plan. Experience with statistical analyses.
• Advanced communication and technical writing skills: Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar.
• Problem Solving: Must demonstrate the ability to solve moderate to highly 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.
• Interpersonal skills: Educates internal and external customers on facts by taking into account differences in level of understanding, needs, and expectations.

Function

Quality

Sub Function

Manufacturing Quality Assurance

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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.

Teva Pharmaceuticals