Job Title: Quality Assurance Specialist
Description:
As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality oversight of our facility. You will be responsible for guaranteeing the validation and qualification status of our production site, equipment, training of personnel, and management of quality documentation.
Key Responsibilities:
- Contribute to assuring the validation/qualification status of the production site, equipment, and personnel.
- Provisional release for shipment of batches.
- Work in shifts with other QA officers to oversee production and quality control activities.
- Archiving and managing site GMP documentation.
- Review of batch records and timely closure of manufactured batches.
Maintenance of Local Quality System:
We are committed to maintaining our local quality system as per GMPs and corporate guidelines. You will ensure the respect of GMPs and Health Authorities requirements at a local level.
Support to QP:
You will support the QP in preparing batches release documents and involvement in investigation of deviation, OOS, complaints, CAPA, change control implementation, and redaction.
Audit Support:
Collaborate and support during external audits by authorities and corporate audits. You will contribute to redaction and review of SOPs, records, protocols, and reports according to GMPs, National/Corporate Guidelines, and health authorities' requirements.
Requirements:
- Previous experience in a similar role within a sterile pharmaceutical or biotech environment.
- Ability to work in shifts, including night shifts and weekends (on a regular basis).
- Fluent in Italian. Good knowledge of English.