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Quality Assurance Officer

CONTEXT:

The selected candidate will join the Quality Assurance Department, in the GMP Compliance dedicated team. Reporting to the Area Manager he/she has full knowledge  of GMP rules and other regulations related to injectable drugs production. 

MAIN ACTIVITIES AND RESPONSIBILITIES:

  • To manage investigation of deviations and claims, contributing to identify the root cause and to define the CAPA in collaboration with other departments;
  • To coordinate risk analysis activities during the investigation of deviations and claims;
  • To manage CAPA in order to improve the Quality System
  • To contribute to assure compliance to quality regulations and internal SOP (GMP Compliance)
  • To audit internal department according to internal planning and provide related report
  • To review and update the internal SOP
  • To review the master batch record
  • To train the production people and Quality Control employee on GMP rules 

JOB REQUIREMENTS:

  • Bachelor Degree in Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry is mandatory;
  • 1 year of previous experience in the Quality Unit of Pharmaceutical Industry environment is preferred;
  • Fluent in English, both written and oral;
  • The candidate should have excellent organizational and analytical skills, capability in working in a team and good problem solving attitude

LOCATION: Florence - HQ

 

Degrees of interest: Bachelor Degree in Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry

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