Band

Level 3

Job Description Summary

The 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 Desired

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