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Contract Manufacturing Organisation Specialist (Temporary)

Date: Oct 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 candidates for the position of Contract Manufacturing Organisation Specialist (Temporary), part of Third Party Operations (TPO) Quality Team, based in Sofia.
 

The role

 

The primary purpose with the position is to guarantee that current pharmaceutical standards, legal regulations and approved registrations are implemented for the production and the controlling of Third Party manufactured products.

 

Main responsibilities

 

      Product Management
•    Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality
•    Take needed actions to ensure the products quality and compliance
•    Providing the necessary support in tasks execution or meetings related to critical quality issues to provide a thorough and profound basis for decision-making
•    Support implementation of projects within the department Quality TPO EU Generics to ensure compliance with internal standards

      Supplier Management
•    Act as a contact person for all issues concerning pharmaceutical quality of Third Party Manufactured products 
•    Provide coordination and control of all GMP relevant documents with regards of manufacturing, quality control and quality assurance.
•    Collect and evaluate status of quality improvement actions as derived from audits, deviation and complaint investigations, risk assessments
•    Provide Quality and Performance KPIs, report audit outcomes and other major quality events or concerns

      Change Management
•    Support/ perform the initiation, coordination and evaluation of new product introductions and product changes to ensure projects success and regulatory compliance
•    Ensure that all changes concerning Module 3 of a dossier are submitted to the authority in collaboration with the vendor and Regulatory Affairs department

      Ad hoc Tasks
•    Supplier Qualification - QA Due Diligence of Contract Manufacturer and perform GMP Documents Authorization to assure regulatory compliance on product and supplier’s level
•    Support the negotiation, preparation and approval of new QTAs ensuring the compliance with the applicable Teva standards and regulations.
•    Ensure that all suppliers in portfolio are audited as per agreed frequency and the follow up of Audits’ CAPAs completion by the Suppliers 
•    Support in all activities needed to close critical quality issue (meeting organization, follow up on Investigations, CAPA and remediation activities for such issues etc.)
•    Initiation & Oversight on Product Quality Reviews (PQRs) for medicinal products manufactured by 3rd parties 
•    Support the creation and maintenance of standard operational procedures and working instructions according to Teva norms and in line with applicable legislation

 

Main Requirements

 

•    University degree in Pharmaceutical, Chemistry, Biology, Engineering science
•    2 years professional experience either in quality control/analysis or assurance role 
•    Regulatory Affairs experience would be considered as an advantage
•    Strong knowledge of MS Office applications,
•    Knowledge of SAP instances, TrackWise and EDMS would be considered as an advantage
•    Excellent communication skills
•    Organizational and planning skills
•    Excellent diplomacy and influencing skills
•    Good command of written and spoken English language; other European language is a plus
 

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

 

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.