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Senior Manager Quality Assurance

Date: Jun 24, 2022

Location: Troyan, BG, 5600

Company: Teva Pharmaceuticals

Company Info

 

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 a 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 suitable candidate for the position of Senior Manager Quality Assurance. This position will be based in Troyan.
 

About the position

 

This role requires Quality Assurance (QA) oversight of GMP activities: establishment, implementation and maintenance of the Quality Management System in support of Product/Process development, manufacturing, packaging, handling, storage and testing of GMP batches in compliance with the Teva global standards, requirements and applicable regulations.

 

Main responsibilities

 

•    Ensures that the research and development (R&D) site procedures and practices are aligned with  the applicable regulations and Teva’s global policies and standards
•    Manages the QA oversight of R&D projects within the Teva Sites and/or 3rd Party Sites
•    Acts as the QA representative for the team and project meetings, and hosts QA meetings as applicable
•    Reviews and approves analytical methods/ validation/ method transfer documentation as well as other documentation needed for NDA/ANDA filings
•    Reviews and approves initial validation and qualification documentation for utilities, manufacturing/ laboratory equipment
•    Reviews and approves executed batch records and certificate of analyses, stability data and stability related documentation
•    Acts as the QA representative during technology transfer and new project meetings
•    Support the development of semi- solid pharmaceutical products 
•    Establishes Key Performance Indicators and provides product status reporting to the site management on product quality and compliance risks with proposed solutions for improvement of the quality and compliance systems
•    Oversees the R&D supplier management program including evaluation, qualification, approval and change management of suppliers, materials, service providers and other
•    Ensures that all investigations, CAPAs and change controls reviews requiring QA review/input are complete according to the company policies and procedures
•    Manages and oversees the site-training program for GMP activities. Conducts trainings for newly implemented or revised procedures
•    Hosts Regulatory and Teva Global Risk Assessment Audits
•    Performs internal and external GMP audits
 

Main requirements

 

•    Bachelor degree in Science, Engineering or related field 
•    Master degree in Pharmacy or Chemistry is an advantage
•    Minimum 10years of work experience from pharma, preferably in quality assurance environment or an equivalent combination of education and experience
•    Significant experience in Quality Management, R&D, change and project management
•    Expert knowledge of regulations (FDA, EMA, ASTM, ANSI)
•    Good understanding of USP/EP methodologies and ICH guidelines 
•    Proven ability to plan resources and manage priorities to consistently deliver on time against tight project deadlines 
•    Ability to work independently and to solve problems
•    Ability to effectively and clearly communicate in English- both written and verbal
•    Good computer literacy skills in MS Office package
 

We Offer

 

•    Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
•    Competitive remuneration bound with performance
•    Additional healthcare insurance
•    Opportunities for career development

 

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.