TEVA Pharmaceutical Industries Ltd. 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!
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 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. Scope of the position includes external Vendor audits and internal Corporate Quality audits of Teva sites. Will also include insuring Teva sites have robust inspection readiness plans in place to insure smooth regulatory agency inspections and successful product launches.
- 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
- 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)
- Bachelors degree in a scientific discipline a must. Master’s degree in a scientific discipline is preferred
- 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
For immediate consideration, please email your resume to firstname.lastname@example.org (No third party recruiters please)
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.