1+ months

Senior Quality Assurance Auditor

Parsippany, NJ 07054

Company Info

Teva is a global pharmaceutical leader and the worlds 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 worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and weve 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 sites with their inspection readiness program and periodically performs special assignment visits focusing on key gaps that require immediate remediation.

 

 

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.

 

This position is located in 400 Interpace Parkway Parsippany, NJ 07054

 

For more on Teva, check us out at www.tevapharm.com or www.tevausa.com.

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 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 Tevas 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
  • Masters 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

 

 

Function

Quality

Sub Function

Quality Compliance

Reports To

Director Quality Global Audits

Tevas 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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Categories

Posted: 2019-06-28 Expires: 2019-11-17

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Quality Assurance Auditor

Teva Pharmaceuticals
Parsippany, NJ 07054

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