Quality Assurance Specialist
The Quality Assurance (QA) Specialist must be the RP back up for Formello plant and also maintains theQuality system for the assigned distribution center, including projects. He/Shecommunicates Quality policy and objectives and ensures prescribed objectivesare met. This position assists with internal audits and validation of theQuality system and processes and participates in assessing the risk andcompliance implications of clients' products and pending business opportunities.The QA Specialist assists with reviewing and approving procedures andinterfacing with relevant regulatory agencies to understand and support theapplication of applicable rules and regulations.
• Own/ write/ review Procedures, Work Instructions, andtechnical documents;
• Performs training programs in SOPs, work instructionsand regulatory topics;
• Management of Non conformities; Management of ChangeControls;
• Follows up the CAPA actions in order to get themimplemented on time;
• Scheduling, preparation and perform internal andexternal audits;
• Ensure equipment calibration and maintenance programare met;
• Under the direction of the Healthcare Compliance (QA)Management, conducts Management Reviews;
• Provide support for validation activities;
• Collaborates in the reception of corporate audits andregulatory agencies audits;
• Collaborate to ensure that the vendors are properlyapproved;
• Assist with the implementation and maintenance of theQuality Management System in accordance with ISO 9001 and 13485 standards;
• Collaborates with the Responsible Person to ensurethat: the recall process is properly managed, the return process are properlymanaged, compliance with legislation related to narcotics and psychotropic aremet;
• Supervises the temperature monitoring through allsteps;
• Assures that all the processes regarding the warehouseactivity (storage, vehicles inspection, products inspection, picking &Packing, etc) are performed according to approved procedures or workinstructions and according the GDP and GMP regulations.
Job Specific competencies
• Professional authorization according with Italianlegislation (Iscrizione all'albo);
• Good knowledge of English;
• Good knowledge of Microsoft Office;
• Knowledge of GMP and/ or GDP.
• Ability to prioritize decisions;
• Good organizational skills;
• Identify potential gaps in the processes and makerecommendations for possible improvements;
• Implementation of new processes having a qualitycritical impact on the business;
• Flexible in working hours.
• Knowledge of electronic Quality Management Systemand/or Warehouse Management System (WMS, GWS etc.) is considered a “plus”
What we offer
• Permanent and Full Time contract.
• The position is based in Formello (Rome) but availableto travel and to relocate
Education and Work Experience
• Master degree in Pharmacy, Chemistry, CTF;
• Experience with ISO 9001 and/or ISO 13485;
• Required mínimum 2 years of experience in companies such as manufacturer/ laboratories/ distributors of pharmaceutical products.
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