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Job Title: Qualification & Validation Specialist
Location: Siena - Italy
Department: QA

Philogen S.p.A. is a biotechnology company whose mission is the development of biologic products for the imaging and therapy of life-threatening diseases, with a special focus on angiogenesis related disorders.

Philogen S.p.A. would like to hire a Qualification & Validation Specialist who will insert in the Quality Unit.

In particular the successful candidate will be responsible for:

  • Management of qualification plans;
  • Editing and Verification of the qualification and validation documents;
  • Drafting of thermal validation study protocol and report;
  • Drafting, verification and execution of protocol and qualification test (FAT, SAT, IOQ, PQ);
  • Performing validation test run and activities;
  • Drafting and monitoring the VMP activities;
  • Supporting in the qualification activities for equipment and utilities e.g., HVAC, Water System, Process Gasses;
  • Supporting maintenance dept for calibration and maintenance plans and instruction;
  • Facilitating the continuous improvement in quality issue;

The ideal candidate should have:

  • In Engineering, Chemistry, Biotechnology, CTF etc.;
  • Minimum 3-4 years of experience in pharma;
  • Knowledge in GMP;
  • Knowledge of the main methodologies for the risk-based approach (FMEA, HACCP, …);
  • Knowledge of the main validation/calibration instruments: thermal validation logger, data acquisition system, calibration instruments, etc.;
  • Knowledge of validation procedure and process: VMP, FAT/SAT, IQ, OQ, PQ;

We offer: 

A contract and salary proportional to the experience (seniority) of the successful candidate.

Job location:

Siena -Italy

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

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