Posted to MedZilla on 8/19/2017


Italy, Deviation Investigator, Sterile Manufacturing QA_OB_13034-MZ


Our client is one of the most prestigious pharmaceutical companies in the world who operate a world class Grade A sterile facility in Southern Italy. They are currently searching for Deviation Investigators to join them on a 3-month rolling basis. The project is likely to go on long term but will be offered on a 3-month rolling basis.

You will be required to:

  • Assist in investigating deviations and writing investigation reports;
  • Formulate investigation plan, gather relevant documentation (e.g, SOPs, batch production records, equipment logbooks, test records, validation reports, etc.) interview relevant personnel (e.g. production, maintenance, tech. services, etc.), develop root cause analysis, determine scope/impact, and develop corrective/preventive actions;
  • Assist in determining the actions and closure of change controls and the corrective and preventive action (CAPA);
  • In furtherance of the evaluation and verification of deviation investigation, change control and CAPA activities, provide on-site expertise at the facility to serve as a working consultant to Quality Senior Management;
  • Interact with site and above site personnel during the course of the investigation and through its completion and approval.

The successful candidate will have a strong background in operational quality within the pharmaceutical sector. You must have previous experience of working in a Grade A sterile manufacturing environment. You will have a proven track record in investigating deviations under sterile manufacturing conditions. You will have experience of investigating and writing deviations, ideally relating to sterile processing equipment such as autoclaves, lyophilizers, freezers, washers, dehydrogenation tunnels.

This is an exciting opportunity to join a large multinational in a diverse role that will offer great exposure to highly sought-after project experience. The role is set in a wonderful location and brings a great lifestyle with low cost of living. The project offers a generous rate of pay, paid on an hourly basis with 50 hours per week available. There is a 4-week rotation pattern, where every fifth week you can take a five day break to return home to see your family. By taking this role you will gain exposure to one of the most dynamic projects happening in the industry today with one of the best recognised brands in the industry.

If this particular opportunity is not of interest to you but you are able to recommend somebody else to me, please bear in mind that I can offer a referral bonus of €200 if they are successful in their application.

KEY WORDS: Sterile, Aseptic , Pharma, Pharmaceutical, Bio, Biotech, Biotechnology, Clean Room , GMP, cGMP , QA, Quality Assurance, Compliance , Auditors, Auditing, Regulatory, Microbiology, Quality Control, QC, Deviation, CAPA , Corrective Action, Preventative Action, autoclave, lyophilzer, freezer, washer, dehydrogenation tunnels

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