1+ months

Quality Analyst III

Parsippany, NJ 07054
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!

 

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

Job Description

Responsible for insuring all drug, biologic, combination or device products produced by Tevas Third Party external manufacturing and packaging partners meets the established standards of quality including reliability, usability and performance.

Key Responsibilities

  • Insure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.
  • Responsible for release of product manufactured and/or packaged at Tevas Third Party Suppliers located in the U.S.
  • Provide Quality oversight for all manufacturing/packaging/testing at Tevas Third Party Suppliers.
  • Draft new and revise existing Quality Assurance policies (SOPs) based on the needs of the department.
  • Evaluate Standards and Regulations against local SOPs to identify and eliminate gaps in policies.
  • Prepare and maintain metrics for reporting Quality data including those for key performance indicators (KPIs).
  • Prepare, negotiate and amend new and existing Quality Technical Agreements.
  • Receive, review and approve Quality Customer Complaint investigations, non-conformance reports and Laboratory Investigations ensuring all necessary components are included.
  • Analyze data to identify areas for improvement and/or trends in the Quality System.
  • Develop, recommend and monitor corrective and preventive actions (CAPA) and CAPA effectiveness reviews within the TrackWise system.
  • Prepare reports and/or presentations for Quality Management to communicate outcomes of quality activities.
  • Identify training needs and organize training interventions to meet quality standards.
  • Evaluate audit findings and implement appropriate CAPA.
  • Evaluate Third Party Supplier Annual product Reviews (APRs) against internal SOPs to identify trends and ensure a continued high level of quality.  
  • Review, evaluate and approve change controls from Third Party Suppliers and act as the point of contact for all comments between internal departments and the site.
  • Communicate to senior level management critical issues that may impact product on the market or product intended for the commercial market.
  • Review and approve validation protocols and reports for activities occurring at Third Party Suppliers.
  • Represent the TPO Quality department and act as the primary contact for various cross functional teams involving product transfers, new product launches, supply chain activities, etc.
Qualifications

Education and Experience

  • Bachelors degree with a minimum of five (5) years experience in a Pharmaceutical FDA regulated industry in Quality Assurance or related field.
  • Must have working knowledge of cGMPs, CFR, ICH and applicable international regulations/guidelines.
  • Certifications such as Quality Auditor, Quality Engineer, Quality Improvement Associate Quality Control and Compendial knowledge and/or Six Sigma are a plus.
  • Experience with Investigations, Change Controls, Product Release, CAPA, Validations, preferred. 
  • Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.
  • Strong computer skills including TrackWise, Oracle and SAP is desired
Function
Quality
Sub Function
Supplier Quality
Reports To

Quality Manager

Tevas 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.

Categories

Posted: 2019-09-06 Expires: 2019-12-16

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Quality Analyst III

Teva Pharmaceuticals
Parsippany, NJ 07054

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