Teva Pharmaceutical Industries Parsippany , NJ 07054
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 Global Quality Auditor performs 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 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 Teva's annual audit work plan and agreed GMP standards.
The scope of the position includes external Vendor audits and internal Corporate Quality audits of Teva sites. In addition, this position will have responsibilities to ensure our Teva sites have robust inspection readiness plans in place to ensure smooth regulatory agency inspections and successful product launches.
Essential Duties and Responsibilities
Scheduling, preparation, conduct, documentation 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
Support of requesting Teva site with supplier qualification issues and supplier risk assessment based on audit result when required
Support of 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)
Application of electronic audit database and audit workflow system for the documentation of audits
Readiness to travel at least within the Americas for audit purposes in due consideration of Teva's business travel global policy.
Required education: Bachelors in Scientific Discipline, preferred Masters in Scientific Discipline
Experience Required: At least 5-7 years experience as a Quality Auditor, with at least 75 audits performed as a Lead Auditor
Preferred experience: At least 5-7 years experience as a Quality Auditor, with at least 80-100 audits performed as a Lead Auditor. Previous experience with a regulatory authority (FDA)
Has sufficient experience in pharmaceutical production, QA or QC, or combined experience, familiar with international GMP regulations and guidelines
Style, tone and language need to be consistent with standard business English
Prepare technical/complex written materials that are accurate, clear, logical, well organized and contain proper grammar, punctuations and spelling
Can perform independent and objective decision making during audits
Strong communication skills, must be able to review, interpret and discuss pharmaceutical regulations and their current application.
Can be in constant improvement by self-study, be sensitive to details (should be scrupulous)
Director Quality Global Audits
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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Nearest Major Market: New York City
Nearest Secondary Market: Newark