formateur-dame

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).

Formation

Validation des méthodes d’analyse (secteurs pharmaceutiques/cosmétiques)