1+ months

Quality Assurance Auditor III

Parsippany, NJ 07054

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed toimproving health and increasing access to quality health solutions worldwide. Our employees are at the core ofour success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 millionpeople every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built apromising pipeline centered around our core therapeutic areas. We are continually developing patient-centricsolutions and significantly growing both our generic and specialty medicines business through investment inresearch and development, marketing, business development and innovation. This is how we improve health andenable 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 onthe first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee StockPurchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com orwww.tevausa.com

Job Description

**This role can sit remotely anywhere in the US**


Will perform GxP audits of pharmaceutical manufacturing, packaging/ labeling, laboratory controls, technical services, storage &distribution and quality systems for sterile/non-sterile APIs, drug products, medical devices, combination products, packagingmaterials and services.


GxP audits are normally taken place in the US and EU on behalf of Teva sites and business partners worldwide. They are scheduled,prepared, conducted and followed up by the auditor based on Tevas annual audit work plan and agreed GMP standards.


Scope of the position includes external Vendor audits and internal Global Risk Assessment (GRA) audits of Teva sites, however theprimary focus will be Tevas internal Global Risk Assessment audits and Tevas critical CMO vendors. The scope also includesinsuring Teva sites have robust inspection readiness plans in place to insure smooth regulatory agency inspections and successfulproduct launches. In addition leading and participating in process improvement projects and initiatives to continue to strengthen theGlobal Audit organization.


Key Responsibilities:
Scheduling, preparation, conduct, documentation and follow-up of assigned GxP audits in accordance with Teva corporatestandards
Initial assessment of audit deficiencies, corrective and preventive actions, and overall vendor/site compliance status based onregulatory GMP requirements and specific Teva requirements
Communication to stakeholders on potential risk and product impact from observations and GMP deficiencies found during youraudits
Provide support to Teva site with supplier qualification issues and supplier risk assessment based on audit result whenrequired/requested
Support notification to management process in case of critical audit findings in collaboration with audit regional lead and auditplan owner
Regular participation in GMP trainings (internal/external)



Must be able to travel approximately 75% --both domestic and international
**This role can sit remotely anywhere in the US**

Qualifications

Function

Quality

Sub Function

Quality Compliance

Reports To

Director, Global Quality Audits

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.

Categories

Posted: 2021-03-12 Expires: 2021-05-12

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 Assurance Auditor III

Teva Pharmaceuticals
Parsippany, NJ 07054

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