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Quality Specialist III - Steriles/Devices

Date: Aug 28, 2021

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

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 or www.tevausa.com

Job Description

Will ensure all drug, biologic, combination or device products produced by Teva’s Third Party external manufacturing and packaging partners meets the established standards of quality including reliability, usability and performance.


Key Responsibilities:
•    Assure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.
•    Collaborate with suppliers to assure the quality of their products, materials, components and/or operations.
•    Monitors supplier KPIs and supports efforts to develop and implement improvements to performance
•    Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented.  Includes supplier audits.
•    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.
•    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.
•    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
•    Provide training, support, and guidance to other Quality Analysts

 

**This position can sit at our Parsippany, NJ HQ location or, potentially, our North Wales or West Chester PA locations**

Qualifications

Education
•    Bachelor’s degree in a related scientific or technical discipline
•    Certifications such as Quality Auditor, Quality Engineer, Quality Improvement Associate and/or Six Sigma are a plus. 

 

Experience
•    Minimum of 5 years’ experience in a Pharmaceutical FDA regulated industry in Quality Assurance or related field.
•    Must have in-depth knowledge of cGMPs, CFR, ICH and applicable international regulations/guidelines.
•    Experience with medical devices, combination products and/or aseptic/sterile products 
•    Experience with Investigations, Change Controls, Product Release, CAPA, Validations, required.
•    Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.
•    Able to resolve complex problems and contribute to process improvements 
•    Works independently with minimal guidance
•    Strong technical writing skills
•    Strong computer skills including TrackWise, Oracle and SAP is desired.

Function

Quality

Sub Function

Supplier Quality

Reports To

Director, Third Party Quality, Americas 

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.

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.

We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.


Nearest Major Market: New York City
Nearest Secondary Market: Newark