Novartis
QualityAssuranceOfficer
“Quality Assurance Officer at Novartis. Skills: Quality Assurance, GMP, Documentation Management, Deviation Investigation, CAPA, Change Control. guarantees the quality oversight over the entire working time of the facility for all the ongoing GMP activities. assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentation”
What You'll Achieve.
guarantees the quality oversight over the entire working time of the facility for all the ongoing GMP activities; assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentation; provisional release for the shipment of batches; assure the timely closure of the manufactured batches; 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
Industry & Context.
investigation of deviation, OOS, complaints, CAPA, change control implementation and redaction
Available to work in shifts, including night turns and weekends on a regular basis
What They're Looking For.
Must Have
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, Fluent in Italian, Good knowledge of English
What You'll Do.
guarantees the quality oversight over the entire working time of the facility for all the ongoing GMP activities
assuring the validation/qualification status of the production site
training of personnel and management of quality documentation
provisional release for the shipment of batches
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
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
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
protocols and reports according to GMPs
National/ Corporate Guidelines and health authorities’ requirements
How You'll Work.
Team & Collaboration
Work in shift with other QA officers; Collaborate and support during the external audits by the authorities and corporate audits
Communication Scope
Fluent in Italian; Good knowledge of English
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