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Quality Contract Manufacturing Operations (CMO) Manager

Date: Jun 3, 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 Contract Manufacturing Operations (CMO) Manager, based in Sofia.

 

The role

 

The role is accountable to guarantee that current pharmaceutical standards, legal regulations and approved registrations are implemented for the production and the controlling of Third Party manufactured products. This position reports into Sr. Manager Vendor Management.‎

 

Main Responsibilities

 

Product management
• Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality.
• Taking actions needed to assure the products quality and compliance. In addition, initiation, coordination, supervision and functional assessment of activities that are carried out by the relevant expert team for this purpose

 

Supplier Management
• Act as an internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products. Coordination and controlling of all GMP relevant documents with regard to manufacturing process, quality control and quality assurance. CMO interacts with TPM/Total Productive maintenance and involved departments of the Teva group.
• Support of the Quality Relationship Manager

 

Change Management
• Ensure that all changes concerning Module 3 of a Registration dossier are submitted to the authority in collaboration with TPM and RA/Regulatory Affairs

 

Supplier Qualification (on-going)
• QA Due Diligence of Existing Contract Manufacturer: Check of GMP status based on audits and complaints
• Authorization of  Master Documents

 

Technical Visits/Audits
• Preparation and realization of national and international technical visits in cooperation with other Teva departments

 

Review of PQRs / Procedure Qualification Records
• Review of the PQRs for completeness and plausibility

 

Release of GMP Documents
• Approval of GMP documents without regulatory impact

 

QC Documentation
• CMO officer ensures the implementation of approved release and shelf life specifications and all corresponding methods by CMO and Teva laboratories. Ensuring the compliance of methods to GMP standards and the dossier

 

Main Requirements

 

• Bachelor’s degree in Pharmaceutical/Natural/Engineering science or related field
• 3+ years’ experience in quality control / analysis, production and / or quality assurance 
• Must have working knowledge of cGMPs  and applicable international regulations/guidelines
• Strong computer skills including MS Office , TrackWise and SAP 
• Good communication skills and resilience
• Good command of the 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.