Job Title: Quality Assurance Auditors—Multiple Openings

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!

About Our Global Quality Audit and Inspection Group

Our Global Quality Audit & Inspection Group is a team oriented department with colleagues across the globe, with regions in the Americas, Europe and APAC and the Far East.  You will have the opportunity to work with several Group colleagues during audits when we perform our Global Risk Assessment (GRA) audits of our internal Teva sites.  Not only does the audit team identify observations and gaps at the site, you will also assist in remediation activities as members of cross functional teams.  The team also supports internal Teva site with their inspection readiness program and periodically performs special assignment visits focusing on key gaps that require immediate remediation.

 

Job Description

Position Summary

You will perform GMP/GDP 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.

GMP/GDP audits are normally take 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 Teva’s annual audit work plan and agreed GMP standards.

Audit scope includes external Vendor audits and internal Corporate Quality audits of Teva sites .You Will also insure Teva sites have robust inspection readiness plans in place to insure smooth regulatory agency inspections and successful product launches.

 

Key Responsibilities

  • Scheduling, preparation, conducting, documenting and follow-up of assigned GMP/GDP audits in accordance with Teva corporate standards
  • Initial assessment of audit deficiencies, corrective and preventive actions, and overall site compliance status based on regulatory GMP requirements and specific Teva requirements
  • 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 hub manager and audit plan owner
  • Regular participation in GMP trainings (internal/external)

Qualifications

Education

  • Bachelors degree in a scientific discipline a must
  • Master’s degree in a scientific discipline is preferred

 

Key Requirements

  • Minimum 5 years experience as a Quality Auditor in a regulated pharmaceutical environment with a minimum of 75 audits performed in a Lead Auditor role
  • Strong working knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
  • Experience with a regulatory authority, e.g., FDA is desirable but not required
  • Fluency in written and spoken English
  • Experience preparing technical/complex written materials that are accurate, clear, logical, well organized and grammatically sound
  • Must be able to travel approximately 75% –both domestic and international

To Apply: https://careers.teva/job/Parsippany-Quality-Assurance-Auditor-III-New-07054/475733500/