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Quality Assurance Auditor II (Remote - US Based)

Date: Nov 21, 2021

Location: Miami, Other/Not Applicable, US, 00000

Company: Teva Pharmaceuticals

Company Info

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.

 

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

Job Description

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 Americas Region 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 the primary focus will be Teva’s external vendors.  The scope also includes 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 50% --both domestic and international 

 

**This is a remote position - can sit anywhere in the US**

Qualifications

•    Undergraduate/BSc degree in applicable discipline required

•    7+ years' of experience required as a Quality Auditor in a regulated pharmaceutical environment

•   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

Function

Quality

Sub Function

Supplier Quality

Reports To

Dir Quality Global Audits, Regulatory Compliance 

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.