Junior Qualified Person

Job description

We are hiring! For our office in Anagni we are looking for a Junior Qualified Person

Your Role

Your Responsibilities

• Resource should be eligible to be named as Qualified Person (Dlgs 219/2006 and subsequent amendments and additions) and as Responsible Person at the pharmaceutical site.
• Manage training and audit programs and Ensure that relevant customer complaints are dealt with effectively;
• Manage qualification of suppliers, system and equipment and manage returned, rejected, recalled or falsified products;
• Manage the right identification, investigation and reporting of compliance issues, irregularities, and he violations;
• Approve and manage CAPA Plan implementation;
• Assure that temperature monitoring of warehouse and critical systems are GXP compliant;
•  Assure that procedures and operating instructions are updated, approved and available in  support to all processes;
• Participate in the review of the processes, pushing towards the innovation of the entire quality process;
• Support in the preparation of documentation for AIFA and other regulatory bodies new applications;
• Management of psychotropic drugs according to D.P.R. 309/90 and subsequent amendments and additions.
• He/She will assure availability of Import/Export permits according to Customer's requests. He/She will assure that any mandatory notifcation will be appropriately and on time sent to the Ministry of Health;

Your Skills and Experiences

• Master's or Bachelors degree in Biology, Pharmacy or Chemistry 
• Experience in multi-customer logistics in the pharmaceutical sector
• Experience in the field of compliance in Pharma Company is a plus
• Excellent use of Excel and data analysis
• Advanced English level
• Driving license and own car
• Request for time flexibility during the induction period