1+ months

Senior Quality Assurance Auditor

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


This position is located in 400 Interpace Parkway Parsippany, NJ 07054

Job Description

 

Position Summary


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, packaging materials 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 the primary focus will be Tevas internal Global Risk Assessment audits and Tevas critical CMO vendors.  The scope also includes insuring Teva sites have robust inspection readiness plans in place to insure smooth regulatory agency inspections and successful product launches.  In addition leading and participating in process improvement projects and initiatives to continue to strengthen the Global Audit organization.


Key Responsibilities

 

    Scheduling, preparation, conduct, documentation and follow-up of assigned GxP audits in accordance with Teva corporate standards
    Initial assessment of audit deficiencies, corrective and preventive actions, and overall vendor/site compliance status based on regulatory GMP requirements and specific Teva requirements
    Communication to stakeholders on potential risk and product impact from observations and GMP deficiencies found during your audits
    Provide support to Teva site with supplier qualification issues and supplier risk assessment based on audit result when required/requested
    Support notification to management process in case of critical audit findings in collaboration with audit regional lead and audit plan owner
    Regular participation in GMP trainings (internal/external)
    Must be able to travel approximately 75% --both domestic and international

Qualifications

 

Education and Experience

 

    Undergraduate/BSc degree in applicable discipline required
    Minimum 10 years of experience required as a Quality Auditor in a regulated pharmaceutical environment with a minimum of 75 audits performed in a Lead Auditor role

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: 2020-07-31 Expires: 2020-09-30

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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Senior Quality Assurance Auditor

Teva Pharmaceuticals
Parsippany, NJ 07054

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