Quality Contract Manufacturing Operations (CMO) Manager

Quality Contract Manufacturing Operations (CMO) Manager

Teva

Sofia, Bulgaria

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

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Bulgaria     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Teva    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies