RAMPONT Valérie (EFOR-CVO)

Compétences

Quality control :

• Supervision and management of :
  • Plannings (analysis, qualifications, trainings, etc.).
  • Documentation : user manuals, analytical methods, monographies, specifications (raw material, IPC, finished product), protocols, reports, URS.
  • Samples, reagents, standards, retain samples.
  • Stability studies : programs and follow-up.
  • Sub contractors, suppliers, customers.
• Results analysis interpretation, review and validation.
• Define and supervise analytical method validation and transfer.
• Define and manage equipment investment, maintenance, qualification and electronic system validation.
• Establish and follow CAPA, OOS/OOT, change control, deviations.
• Software : EZChrom Elite, Empower, OpenLab, Ennov Doc, Ph. Eur, USP, MSProject, Endosafe.
• Equipment : HPLC, UHPLC, HPLC/MS, GC, GC/HS, TOC, IR, NMR, Karl Fisher, Densimeter, pH meter, Refractometer, MCS.
• Techniques : Liquide ans gas chromotography, potentiometry, spectrometry, polarimetry, refractometry, TAMC/TYMC, LAL.

Quality :

• Site quality system management : ensure site compliance with GMP, GLP, ICH.
• Defining, quality policy and managing indicators.
• Carrying out and managing audits (internal and external).
• Managing and supporting inspection.
• Regulatory and contractual management.
• Documentation management.
• Storage and archiving management (documentation, data).
• Batch release.
• Change control, corrective actions and preventive actions, deviations, claims management.

Management :

• Human ressources management.
• investment program.
• Training.

Diplôme(s) – Qualification – Certification

PhD in Chemistry and Molecular Physical Chemistry.

Expérience

Experience in Life Sciences (pharmaceutical, biotechnology, cosmetics and chemistry) and in quality (quality control and quality assurance).