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Quality Assurance Manager

Date: Jun 10, 2021

Location: Sofia, BG, 1407

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 qualified and motivated candidate for the role of Quality Assurance Manager, based in Sofia.
 

The Role

 

The Quality Assurance Manager will be responsible for the planning, execution and reporting of investigations to find out the root cause of deviation in the laboratory and/or manufacturing process.

 

Main Responsibilities

 

•    Assuring that the investigation/deviation is performed according to Teva procedures
•    Identification of critical deviations of validated analytical method, qualified analytical apparatus and preparation of facts for the qualified person assessment
•    Coordination of the root cause study, preparation of a risk assessment and restoring the GLP status of the quality control process  
•    Performing risk assessments in case of critical quality events and preparation of deviation reports 
•    Independent categorization of deviations and decision-making responsibility for the affected batches
•    Handling of requests from other Teva sites regarding deviations of the deliveries
•    Evaluation of deviation reports from contract manufacturers with regards to possible impact on the batch release process. Coordination  with responsible Teva release QP/QRM if applicable
•    Participation in customer audits, on-site audits and self-inspection audits according to the responsibility
•    Organization of documents for authorities notification   and data for preparation for NtM and QRMB documents
•    Collection of data/documents and  issuing Notification to management  
•    Organization of documents for authorities notification and initiation of product recall
 

Main Requirements

 

•    Experience in pharmaceutical manufacturing/validation/other related experience and/or in analytical control and regulatory compliance
•    Master Degree in pharmacy, chemistry; similar natural sciences, engineering or at least several years working experience in quality assurance area 
•    Understanding of the drug manufacturing process. Knowledge of generics and branded product development is a plus
•    Good interpersonal and communication skills as well as organizational skills
•    Ability to communicate complex issues to affected departments, decision making to solve problems
•    Good in written and spoken English
•    Proficiency in MS Office-> EXCEL, SAP and TrackWise
 

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
•    Transportation allowance
•    Flexible working hours and option to work from home as per the company policy
•    Opportunity for development
 

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.