Pierre ESTERMANN

En résumé

Entreprises

• F. Hoffmann-La Roche Ltd. - Quality Leader as a Contractor

  2016 - 2017 • Provide Product development Medical Affairs (PDMA) staff with compliance support to ensure that all medical affairs activities are conducted in accordance to the Roche SOPs, guidelines and policies.
  • Provide Quality management support to PDMA and the Affiliates, and deliver a quality oversight plan and metrics.
  • Support the sharing of ‘best practices’ learnings within PDMA and the Medical Network through Self-inspections.

• Covance CLS - Senior Compliance Auditor

  Princeton 2012 - 2015 Experienced and knowledgeable in auditing techniques, regulatory Requirements, process improvement and problem solving skills. develop and implement communication and action plans to ISO 15189 accreditation, serve as author or reviewer of Quality Assurance SOPs.

• Covance - Quality Analyst

  Princeton 2009 - 2012 Responsible for the management and analysis of CAPA (quality issues):
  • Utilizing appropriate problem solving skills, track to resolution all issues reported from internal and external sources via the Trackwise database.
  • Analyze and trend quality data across and within areas to identify process improvement and quality opportunities.
  • Supported investigation teams during investigation of Corrective Actions for Issue Resolution (CAIRs) and reportable issues to drive root cause analysis and effective corrective and preventive action plans.
  • Lead initiative to Improve efficiency of Quality Tracking Management complaint (QTM) process and differentiate QTMs based on risk criteria.

• Covance - General Laboratory Supervisor & Laboratory Compliance Analyst

  Princeton 2002 - 2009 Provided programming support to laboratory departments worldwide to maintain performance of the laboratory activities which includes to creating statistical analysis tables, performing checks on clinical data for possible discrepancy, develop new reports to monitor quality tasks.
  
  Performed Gap analysis and Gap assessment for each of the laboratory systems.
  Responsible for Qualification of Laboratory instruments (DQ, IQ, OQ, PQ)
  Developped of validation protocols and procedures for new and existing equipment,
  Worked with vendors of instrumentation to ensure vendor meets Covance CLS regulatory compliance needs.
  Supervised and coached four general laboratory assistants.
  Learned Management skills and coaching model by participating to five Covance Leadership Development sessions.
  Lead as a Green Belt a Kaizen project (six sigma approach) to reduce delay for generation of the Quality Control reports.
  Lead one MSA project (six sigma approach) on Tests Cancelled Metric in the laboratory.
  Developed and provided training to either newly hire employees or new releases.

• Covance - Laboratory Central Coordinator

  Princeton 1999 - 2002 • Following CAP’s requirements, ensure control and maintenance of all technical installations in the laboratory: Cooling systems, fridges, freezers, centrifuges, etc.
  • As an QA/ QC committee member, ensure the follow-up of security training in Lab, support the findings of the QA Department Log, investigate, resolve and document issues, develop, implement and report lab KRI’s.
  • Maintain (review and edit) departmental SOP’s; participate in generation of new SOP’s; enforce maintenance of employee documentation of individual training folders.
  • Maintain a high level of coordination and liaison between Laboratory and others departments
  • Maintain global coordination with the other Covance Central Laboratory sites.
  • Represent the Laboratory departments to customers and auditors.
  

• Covance - Medical Technologist in Immunology

  Princeton 1996 - 1999 PERFORMING TESTING
  • Ensure specimens to be tested are available
  • Check pending worksheets
  • Prepare material and reagents and related documentation
  • Carry out laboratory testing according to plans and procedures
  ENSURE VALIDITY AND RELIABILITY OF RESULTS
  • Prepare and test controls
  • Check results according to quality control rules in place
  • Make and document suitable corrective actions when needed
  • Processing results : Validate electronically results transfer according to procedures in place
  • Perform linearity and stability tests upon supervisor request
  OPTIMIZE REAGENTS MANAGEMENT
  • Participate actively in suitable cost control of department supplies and reagents
  • Reduce biohazard and chemical wastes as much as possible
  EQUIPMENT MAINTENANCE
  • Perform daily, weekly, monthly and on request maintenance
  • Ensure troubleshooting of simple technical problems within the area
  

• Merck Serono - Medical Laboratory Technologist

  Lyon 1989 - 1994 Production of recombinant human growth hormone (r-hGH)
  Purification of recombinant human FSH & LH by a sequence of chromotographics steps

Formations