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

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 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 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 

Qualifications

Education and Experience
    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
    Fluency in written and spoken English
    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 
    Excellent written and verbal communications and interpersonal skills
    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

Sub Function

Reports To

Dir Quality Global Audits

Already Working @TEVA?

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