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