2 days ago

Quality Systems & Compliance Manager - Temporary position

Bracco Suisse SA

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Bracco Suisse SA based in Geneva (Switzerland) is a company of the international Bracco Group (www.bracco.com), a leader in contrast agents for medical imaging. Our Manufacturing Site based in Geneva is approved and inspected by the most important Regulatory Agencies (FDA, Swissmedic, etc.) and produce a lyophilized contrast agent exported in several countries.Within the framework of a temporary replacement we are looking for:

 

Quality Systems & Compliance Manager - Temporary position

Bracco Suisse SA based in Geneva (Switzerland) is a company of the international Bracco Group (www.bracco.com), a leader in contrast agents for medical imaging. Our Manufacturing Site based in Geneva is approved and inspected by the most important Regulatory Agencies (FDA, Swissmedic, etc.) and produce a lyophilized contrast agent exported in several countries.Within the framework of a temporary replacement we are looking for:

 

Job mission:

  • Establish, design and oversee Quality Systems and compliance in order to assure the Bracco Suisse SA, manufacturing site.

Activities :

The mission encompasses involvement in the following main areas according the current pharmaceutical GMP’s (Europe and USA) and BRACCO corporate Quality and HSE Management System:

Compliance :

  • Improve, maintain and assure a continuous improvement of the local Quality Systems to assure the compliance to current pharmaceutical GMP’s (Europe and USA) and BRACCO corporate Guidelines
  • Follow up on Corporate Guidelines implementation
  • Coordinate a continuous inspection readiness program
  • Manage the Supplier Qualification Assurance (QAA, risk assessment) and supplier deviations
  • Approve packaging and QC specifications
  • Assure the compliance of the site to regulation:
    • QA review for issuance of GMP documents (SOP’s protocols, reports...)
    • Main contact for RA requests
  • In absence of Responsible Person:
    • communication to SwissMedic and compliance to applicable Regulations

Auditing

  • Manage internal and external audits.
  • Lead auditor in self-inspections and external audits.

Quality Systems

  • Manage CAPAs (workflow, meetings with the concerned functions, KPIs)
  • Manage change control
  • Lead the Documentation and training systems; Expresso and Success Factor business owner.
  • Coordinate and prepare Annual Product Reviews with the objective of verifying the consistency of the process
  • Propose a training program and assure a follow up. Organize GMP training for the site
  • Manage and Lead the risk analysis
  • Perform audit trail review of GMP systems

Monitoring and Communication

  • Establishes Compilations, trending of GMP data and Key Performance Indicators (KPI)
  • Diligently report to head of Quality Unit any Quality Alert/issue and actively participate to resolve significant Quality issues when they arise
  • Assure a communication flow and collaboration with Operations and other functions to assure a product life-cycle quality

Backup

  • Backup for quality documentation management and issuance of batch record
  • Backup for compliance approval of QC lab documentation (SOP, specifications, revision analytical dossier QCA & QCM, Analytical method validation documents, stability documents, LIMS modification)
  • Backup in due date extension for CAPA and Change control

Profile:

  • Technical Degree from a University, Engineering School or equivalent in Life Sciences, (e.g. Pharmacy, Chemistry, engineering or related fields)
  • At least 4 years in quality operation management in pharmaceutical industry
  • Experience with Deviations and CAPA management system (eg: Trackwise), Documentation Management system, and SAP
  • Fluency in English and French is required for the role

We offer:

  • The opportunity to join a well-established and successful company with bright prospects and state-of-the-art manufacturing sites and production facilities
  • A great development perspective and the opportunity to bring and utilize your know-how and expertise

 

If you recognize yourself in this profile and are looking for a new challenge, send us your complete application (letter & CV) only by mail, through the JOBUP website.

 

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