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Contract Manufacturing Organisation Manager

Date: Jun 8, 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 a motivated and solution-oriented candidate for the position of Contract Manufacturing Organisation Manager, based in Sofia.
 

About the Position

 

CMO Manager will have 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 actions needed to assure the products quality and compliance - initiate, coordinate and supervise activities that are carried out by the relevant expert team for the purpose
•    Close cooperation with Qualified Persons and Quality Officers as well as responsible Teva departments in tasks or meetings related to critical quality issues to provide a thorough and profound basis for decision-making
•    Implement and support projects within the department to ensure compliance with internal standards

 

   Supplier Management
• Internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products
• Coordinate and control all GMP relevant documents with regard to manufacturing process, quality control and quality assurance
• Collate key quality performance metrics and trends agreed with CMOs
• Collect status of Quality improvement actions (derived from audits, deviation & complaint investigations, risk assessments
• Provide Quality and Performance KPIs, prepare reports on audit outcomes and other major quality events or concerns

 

   Change Management
• Ensure all changes concerning Module 3 of a dossier are submitted to the authority in collaboration with TPM and Regulatory Affairs
• Reply to deficiency letters (DL)

 

   Additional responsibilities
• Supplier Qualification - QA Due Diligence of Existing Contract Manufacturer and Master Documents Authorization to assure regulatory compliance on the supplier’s level
• Participation in Technical Visits/Audits
• Review of Procedure Qualification Records (PQRs)
• Release of GMP Documents
 

Main Requirements

 

• University degree in Pharmaceutical, Natural or Engineering science
• Professional experience either in quality control/analysis/assurance role or in supplier management role in a GxP or ISO regulated environment
• Strong knowledge of MS Office applications, SAP instances and TrackWise QMS
• Excellent communication skills
• Organizational and planning skills
• Excellent diplomacy and influencing skills
• Good command of written and spoken English language
 

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.