Quality Assurance SpecialistPrimary Location: Via Formellese, Km. 4.300 , Formello, Roma - IT, 00060 Job ID 064395
The Quality Assurance (QA) Specialist must be the RP back up for Formello plant and also maintains the Quality system for the assigned distribution center, including projects. He/She communicates Quality policy and objectives and ensures prescribed objectives are met. This position assists with internal audits and validation of the Quality system and processes and participates in assessing the risk and compliance implications of clients' products and pending business opportunities. The QA Specialist assists with reviewing and approving procedures and interfacing with relevant regulatory agencies to understand and support the application of applicable rules and regulations.
• Own/ write/ review Procedures, Work Instructions, and technical documents;
• Performs training programs in SOPs, work instructions and regulatory topics;
• Management of Non conformities; Management of Change Controls;
• Follows up the CAPA actions in order to get them implemented on time;
• Scheduling, preparation and perform internal and external audits;
• Ensure equipment calibration and maintenance program are 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 and regulatory agencies audits;
• Collaborate to ensure that the vendors are properly approved;
• Assist with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards;
• Collaborates with the Responsible Person to ensure that: the recall process is properly managed, the return process are properly managed, compliance with legislation related to narcotics and psychotropic are met;
• Supervises the temperature monitoring through all steps;
• Assures that all the processes regarding the warehouse activity (storage, vehicles inspection, products inspection, picking & Packing, etc) are performed according to approved procedures or work instructions and according the GDP and GMP regulations.
Job Specific competencies
• Professional authorization according with Italian legislation (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 make recommendations for possible improvements;
• Implementation of new processes having a quality critical impact on the business;
• Flexible in working hours.
• Knowledge of electronic Quality Management System and/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 available to 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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