Computer System Validation Specialist

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Irfa******

  • Italy 
  • Last Update: 01.01.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Italy
Country
Italy

Category


Research & Development (R&D)

Description


The role
develop the annual plan for calibration of all instruments in accordance with the provisions regarding GMP and Business Practices;
ensure the implementation of activities necessary for the qualification / validation of equipment / systems and processes
ensure the traceability of all authorized changes (change control)
plan and implement in close collaboration with the senior management a program of internal audits to monitor continuously the effectiveness of the Quality Management System (QMS)
participating in audits, developing a plan of corrective / preventive actions
overseeing the hygiene conditions and on the efficiency of the premises, machinery and equipment of the manufacturing plant;
supporting the Head of Service Quality Control in the preparation and evaluation of protocols
collaborate to review process data and the preparation of pharmaceutical products for regular evaluation reports (Annual Product Review)
close collaboration with the senior management of KPIs of the quality management system (QMS)
training of relevant staff

The Candidate
university degree required: chemistry, industrial chemistry, chemical engineering or mechanical engineering;
written

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