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Validation Specialist

Validation Specialist
Azienda:

Gnosis



Funzione Lavorativa:

Ricerca

Dettagli della offerta

Job Description Execution of all activities related to qualification and periodic requalification of production machines, utilities (e.g.
: HVAC, PRW, Compressed Air, Nitrogen, etc.)
of the areas with controlled contamination, laboratory equipment and the validation of related computer systems (CSV) in compliance with Good Manufacturing Standards, national and international regulations and company policies.
MAIN RESPONSIBILITIES • Perform directly, or with the support of external personnel, the qualification activities (IQ / OQ / PQ and Final Qualification Reports) of plants, machines, utilities, controlled contamination environments in compliance with planning; • Drafting and reviewing qualification protocols for the above GMP equipment  • Collaborate in the drafting of URS and S.A.T./ F.A.T.  • Collaborate with reference figures to evaluate and complete the activities required by change control in the field of qualifications, in compliance with the procedures and timescales.
• Collaborate with the reference figures in the drafting and updating of the sops related to the management/ validation of equipment, utilities and controlled contamination areas.
  Qualifications - Master's degree in technical/scientific subjects; - Goog knowledge of cGMP; - Good knowledge of written and spoken English Additional Information Fixed term contract


Risorsa: Talent_Ppc

Funzione Lavorativa:

Requisiti

Validation Specialist
Azienda:

Gnosis



Funzione Lavorativa:

Ricerca

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