Summary
The QA Officer guarantees the quality oversight over the entire working time of the facility for all the ongoing GMP activities.
Responsibilities
Contribute to assuring the validation / qualification status of the production site, equipment, training of personnel and management of quality documentation.
Responsible for the provisional release for the shipment of batches.
Work in shift with other QA officers to oversight the production and quality control activities.
Archiving and support in managing the site GMP documentation.
Review of batch records and assure the timely closure of the manufactured batches.
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.
Support the QP in the preparation of batches release documents.
Involvement in investigation of deviation, OOS, complaints, CAPA, change control implementation and redaction.
Collaborate and support during the external audits by the authorities and corporate audits.
Contribute to redaction and review of SOPs, records, protocols and reports according to GMPs, National / Corporate Guidelines and health authorities’ requirements.
Qualifications
Scientific degree.
Previous experience in a similar role within a sterile production environment.
Good knowledge of GMP.
Available to work in shifts, including night shifts and weekends (on a regular basis)
Fluent in Italian. Good knowledge of English.
J-18808-Ljbffr
QA Officer • Rome, Italy
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