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Quality Systems & Compliance Manager

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Quality Systems & Compliance Manager
We are recruiting, on behalf of our client, an experienced Quality Assurance Manager to establish, design and oversee Quality Systems and Compliance for the Company manufacturing site.
This position is a temporary contract.

Responsibilities
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 company 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

Contact
Spring Professional Life Science : +41 58 233 40 20

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