Quality Systems & Compliance Manager

06.08. | Temporary | 100%

Quality Systems & Compliance Manager

Kelly scientific is looking for a Quality Systems & Compliance Manager for a maternity leave for a 6-month period.

The position

Establish, design and oversee Quality Systems and compliance of a pharmaceutical manufacturing site under current GMP and corporate guidelines.

Your tasks / duties

Compliance:

  • Follow 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
  • Ensure manufacturing site regulation compliance :
  • QA documentation review (SOP's protocols, reports...)
  • RA requests management


Audits:

  • 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

  • Establish 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
  • Enssure 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


Your Profile

  • Scientific university degree, Master or Bachelor
  • At least 4 years of experience in pharmaceutical industry
  • Strong Knowledge of GDP/GMP regulations
  • Fluent in English and French, both written and spoken


Your contact at Kelly Scientific
Sophie Darthenay
Engineer in Biology
Consultant Professional Staffing Life Science

06.08.2020
Employee, 100%

Contact

Kelly Services Switzerland

Sophie Darthenay


Kelly Life Sciences

rue du Rhône 114Geneve

Industry

Human resources / Personnel services

Kelly Life Sciences

rue du Rhône 114Geneve

Industry

Human resources / Personnel services
Salary

Salary Check

Take advantage of the jobup.ch service to find out how much you earn as Compliance officer.

This website uses cookies to ensure you receive the best service. Further information can be found in our Terms and Conditions and in the Privacy Policy.