Quality Analyst II - 6010

Teva Pharmaceutical Industries Parsippany , NJ 07054

Posted 3 months ago

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!

Job Description

  • Assure 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 Teva's Third Party Suppliers located in the U.S.

  • Provide Quality oversight for all manufacturing/packaging/testing at Teva's Third Party Suppliers.

  • Draft new and revise existing Quality Assurance policies (SOPs) based on the needs of the department.

  • 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 Quality Customer Complaint investigations, non-conformance reports and Laboratory Investigations ensuring all necessary components are included.

  • 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.

  • 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.

  • Be able to 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

  • Bachelor's degree with a minimum of 3 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 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.

Key Competencies

  • Quality: attention to detail and accuracy, committed to excellence, suggests improvements to existing process, identifies root causes, owns and acts on quality issues.

  • Teamwork: meets all team deadlines and responsibilities, listens and values other's opinions

  • Customer Focus: represents Teva in a professional and positive manner. Sets expectations of quality, solicits opinions and ideas and responds to customer quality inquiries.

  • Adaptability/flexibility: adjusts plans to meet changing needs, open to new ideas, takes on new responsibilities.

  • Able to:

  • Communicate well both verbally and written.

  • Collect, manage and analyze data.

  • Analyze and solve problems using existing solutions.

  • Plan, prioritize and organize with minimal management oversight.

Function

Quality

Sub Function

Supplier Quality

Reports To

In process of validation

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Nearest Major Market: New York City

Nearest Secondary Market: Newark


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Quality Analyst II - 6010

Teva Pharmaceutical Industries