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Global Quality Auditor

Date: Aug 6, 2022

Location: Sofia, BG, 1407

Company: Teva Pharmaceuticals

Who are we?

 

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 40,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

 

In August 2016 Actavis has been acquired by Teva Pharmaceutical. In Bulgaria, we are the largest employer in the pharmaceutical industry with near 1700 employees in the two manufacturing plants (Dupnitsa and Troyan); sales and marketing organization and in number of global corporate functions based in our country. As a Teva company, in October 2020 Actavis has started the process of re-branding and anticipating the Teva brand.

 

We are looking for qualified and motivated candidate for the role of Global Quality Auditor, based in Sofia.

 

Position Summary

 

The incumbent 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. 

 

Main 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)
 

Main Requirements

 

•    Undergraduate/BSc degree in applicable discipline required
•    Between 5-7 years of experience required as a Quality Auditor in a regulated pharmaceutical environment (with a minimum of between 30 - 50 audits performed)
•    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
•    Experience preparing technical/complex written materials that are accurate, clear, logical, well organized and grammatically sound
•    Requires in-depth knowledge and experience of audit management and execution 
•    Excellent written and verbal communications and interpersonal skills
•    Strong presentation skills
•    Fluency in written and spoken English
•    Must be able to travel approximately 50%-both domestic and international 

 

We Offer

 

•    Dynamic and challenging work environment in one of the world’s leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
•    Technical trainings to keep and improve the knowledge
•    Competitive remuneration bound with performance
•    Additional healthcare insurance
•    Transportation allowance
•    Flexible working hours and option to work from home as per the company policy
•    Opportunity for development in a fast-growing international company

 

If this sounds like the right opportunity for you, send us your CV in English.
Please, kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.

 

Already Working @TEVA?

 

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

 

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