QA Officer

Descrizione del lavoro:

Job Description SummaryThe QA Officer guarantees the quality oversight over the entire working time of the facility for all the ongoing GMP activities.

Job Description
Major Accountabilities:
* 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.

Essential requirements:
* 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.

Skills DesiredCollaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge