QA Officer

Job Description Summary

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

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 pharmaceutical or biotech environment.

Available to work in shifts including night shifts and weekends (on a regular basis)

Fluent in Italian. Good knowledge of English.

Skills Desired

• Continued Learning
• Dealing With Ambiguity
• Gmp Procedures
• Qa (Quality Assurance)
• Quality Control (Qc)
• Testing
• Quality Standards
• Self-Awareness
• Technological Expertise
• Technological Intelligence

Required Experience

Unclear Seniority

Key Skills

Graphic Designing,Information Technology Sales,IT Services,Accounts,Auto Parts,Import & Export

Employment Type

Full-Time

Experience

years

Vacancy

1