Quality Assurance Auditor I

Who we are?

If you’re like people at Teva, you dare to be different. We’re making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry.

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.

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!

The opportunity

Position Summary
To lead and maintain the site Internal Audit Program and provide support during business partner audits and regulatory inspections. In addition, provide support to monthly quality metrics, Site Quality Council, compliance gap assessments, Inspection readiness and other miscellaneous quality projects.

Key Duties & Responsibilities
1. Help develop and conduct the site Internal Audit Program.
2. Provide support during Teva’s GRA Audits and outside regulatory inspections (e.g. FDA).
3. Provide support to site inspection readiness activities.
4. Assign, monitor and close audit and Regulatory Compliance CAPAs in the TrackWise System.
5. Generate, collect and upload Monthly & Quarterly Metrics.
6. Prepare supporting documentation and facilitate the Site Quality Council.
7. Performs gap assessments to ensure compliance with regulations.
8. Provide support for site investigations.
9. Prepares and submits reports, standards, and other documents as required.
10. Engage in and promote Quality & Operation Excellence.
11. Follows Teva safety policies and procedures.
12. Performs other duties as assigned or required by business needs.

Primary Outcomes
1. Compliance with Internal Audit Program schedule
2. 100% compliance with submitting Monthly & Quarterly Metrics on time
3. Ensure information is prepared on time for Site Quality Councils meetings
4. High quality support for Reg. Compliance CAPAs and investigations.

How you’ll spend your day

Make a difference with Teva Pharmaceuticals

Your experience and qualifications

• Education: B. S. in biology, chemistry, biochemistry, microbiology, or related science
• Experience: B.S. with desired minimum 5 years of experience in a pharmaceutical environment and a solid understanding and knowledge of GMPs.
• Individuals with equivalent combination of education, training, and experience will be considered.
• Company Related Knowledge: Good general understanding of cross functions within TEVA, i.e. QA, QC, Validation, Manufacturing, Packaging and Engineering & Maintenance.
• Experience with Manufacturing/Quality systems such as Trackwise, LIMS/Labware, Crystal Reports,
• Experience with laboratory related testing, processes and procedures preferred.
• ASQ/CQE/CQA Certification preferred
• Technical Knowledge: GMPs, SOPs, FDA Regulations
  

Enjoy a more rewarding choice

Reports To

In process of validation

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.