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Contract Manufacturing Organisation Manager

Date: Mar 14, 2019

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 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

 

Since August 2016 Actavis has been part of Teva. In Bulgaria the combined company is working under the Actavis brand and is the largest employer in the pharmaceutical industry. Actavis - a Teva company - manages two manufacturing plants, sales and marketing organization and a number of global corporate functions.

 

We are searching qualified and motivated candidates for the position of Contract Manufacturing Organisation (CMO) Manager, part of Third Party Operations (TPO) Quality Team, based in Sofia.

The Role:

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 duties and 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

Successful candidates should have:

• 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
• Competitive remuneration bound with performance
• Opportunity for development in a fast growing international company
• Job specific training

If this sounds like the right opportunity for you, apply directly online through the button ‘Apply’ and send us your CV in English.
All personal data is protected by law and will be treated in confidentiality.

Function

Quality

Sub Function

Supplier Quality

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.