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Quality Assurance Auditor III

Date: Jun 7, 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 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 Teva’s 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 Teva’s internal Global Risk Assessment audits and Teva’s 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

• Undergraduate/BSc degree in applicable discipline required
• Minimum 7 years of experience required as a Quality Auditor in a regulated pharmaceutical environment with a minimum of 50 audits performed in a Lead Auditor role

Knowledge, Skills and Abilities
•    Uses best practices and knowledge of internal or external business issues to improve products/services or processes
•    Typically resolves complex problems or problems where precedent may not exist, takes a new perspective using existing solutions
•     Participates in project teams
•    Acts as a resource for colleagues with less experience
•    Requires in-depth knowledge and experience of audit management and execution 
•    Works independently; receives minimal guidance
•    Strong working knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), the rules governing medicinal products in the European Union, WHO and other regulatory requirements
•    Experience preparing technical/complex written materials that are accurate, clear, logical, well organized and grammatically sound

 

Communication
•    Contact with Regional leaders, Global Audit Group team members, and External Vendors 
•    Strong presentation skills

 

Team work and interaction
•    Ability to work in cross functional teams, prioritize workloads, and be responsible for the expected deliverables
•    Manage problem solving and conflicts effectively within the team

 

Focus and Accountability
•    Innovative/creative in the areas of his/her work
•    Willingness to challenge boundaries
•    Organization and attention to detail
•    Adaptable to change
•    Contribute beyond self to the learning and growth of others

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.

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. 

Inclusion & Diversity at Teva 
Empowering our diverse employee base and creating an inclusive culture is both a business imperative and an opportunity to bring us closer to our patients, our partners and our communities. Teva employees respect and embrace a diverse range of experiences, capabilities and perspectives that connect us to new insights and opportunities, while building a more inclusive culture for all. We strive to enable a work environment where all employees can feel engaged and know they are making an important contribution to improving health and making people feel better.


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