Quality Assurance Specialist (Sostituzione Maternità)

The opportunity




In your day-to-day, you'd be responsible for:


• Batch Disposition: Review batch documentation for compliance; manage disposition of raw materials, intermediates, and final AP Is.

• CAPA: Review, approve, and ensure timely execution of CAP As to prevent reoccurrence of issues.

• Complaints: Investigate complaints; issue and review complaint reports; notify suppliers.

• Deviations: Investigate deviations; issue and review reports.

• Notifications to Management: Collect and verify information for notifications.

• Quality Customer Service: Prepare responses to customer requests; verify documentation.

• Quality Overview & Shop Floor: Monitor production and warehouse areas; ensure compliance.

• Quality Shipment/ Logistics: Manage packaging and shipping documentation; review and approve packing lists.

• MS&T and RA Support: Review batch documentation and manufacturing processes for regulatory compliance.

• APR/PQR: Prepare and issue Annual Product Reviews; share with relevant sites and suppliers.

• Change Control Management: Evaluate and implement changes; review and approve risk assessments.

• Cleaning Validation Review: Review cleaning documentation for equipment.

• Document Management: Manage manufacturing procedure documentation; archive batch records.

• Process Validation Review: Review and approve validation documentation.

• Compliance Support: Participate in audits; support inspection readiness.



Your experience and qualifications


Education:

• Bachelor’s degree in Chemistry, Pharmacy, Life Sciences or closely related discipline is required.

• Alternatively, a High School Diploma completed by relevant and verified Training/ Certification for the role can be accepted on an exceptional basis.

Skills:

• Able to work with a good level of autonomy with supervision where necessary

• Ability to work cross-functionally.

• Familiar with Quality IT Systems: i. e. Track Wise

Languages:

• Italian, proficient English 

Minimum Experience / Training required:

•2-5 years of work experience in API/pharmaceutical companies.




What Do We Offer?


We try to take care of our employees, offering them small and large benefits, for example:


• Canteen

• Working flexibility for Caregivers and parents

• Coffee Key 

• Recognition Program

• Welfare Platform

• Health agreement with medical centers of excellence

• Highly inclusive and multicultural working environment

• Continuous learning and development programs