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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 APIs.
•CAPA: Review, approve, and ensure timely execution of CAPAs 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
•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.
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. TrackWise
Languages
• Italian, proficient English
Minimum Experience / Training required:
•2-5 years of work experience in API/pharmaceutical companies.
• 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
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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