QA Officer

<p style="text-align:left"><b>Job Description Summary</b></p>The QA Officer guarantees the quality oversight over the entire working time of the facility for all the ongoing GMP activities.<p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Job Description</b></p><p><b>Major Accountabilities:</b></p><ul><li><p>Contribute to assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentation.</p></li><li><p>Responsible for the provisional release for the shipment of batches.</p></li><li><p>Work in shift with other QA officers to oversight the production and quality control activities.</p></li><li><p>Archiving and support in managing the site GMP documentation.</p></li><li><p>Review of batch records and assure the timely closure of the manufactured batches.</p></li><li><p>Contribute to maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local level.</p></li><li><p>Support the QP in the preparation of batches release documents.</p></li><li><p>Involvement in investigation of deviation, OOS, complaints, CAPA, change control implementation and redaction.</p></li><li><p>Collaborate and support during the external audits by the authorities and corporate audits.</p></li><li><p>Contribute to redaction and review of SOPs, records, protocols and reports according to GMPs, National/ Corporate Guidelines and health authorities’ requirements.</p></li></ul><p></p><p><b>Essential requirements:</b></p><ul><li><p>Scientific degree.</p></li><li><p>Previous experience in a similar role within a sterile production environment.</p></li><li><p>Good knowledge of GMP.</p></li><li><p><u>Available to work in shifts, including night shifts and weekends (on a regular basis)</u></p></li><li><p>Fluent in Italian. Good knowledge of English.</p></li></ul><p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Skills Desired</b></p>Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge