Teva TAPI - Senior Quality Assurance Specialist 

Italy, Lombardy 

676645614

Reporting to the Quality Assurance Manager, you will contribute to maintaining the effectiveness of the Quality System at the site.

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

Batch Disposition:Review batch documentation for compliance before disposition and Manage disposition of raw materials, intermediates, and final APIs with Qualified Person's support.

CAPA:Review, approve, and ensure timely execution of CAPAs to prevent reoccurrence of issues and Implement remediation actions assigned to Quality Assurance.

Complaints:Investigate complaints with Site Quality Head, Qualified Person, and QA Manager and Issue and review complaint reports, notify suppliers of complaints.

Deviations: Investigate deviations with Site Quality Head, Qualified Person, and QA Manager and Issue and review deviation reports, support investigations.

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

Quality Overview & Shop Floor:Ensure quality oversight and monitoring at shop floor, participate in Quality Walk Arounds and Audit production and warehouse operations for compliance.

Quality Shipment/Logistics:Manage and review packaging and shipping documentation and Approve packing lists with Qualified Person's support.

MS&T and RA Support:Review batch documentation per regulatory requirements and Verify manufacturing and packaging processes align with DMF.

APR/PQR:Prepare and issue Annual Product Reviews, share schedules with other sites and suppliers and Review APRs provided by service suppliers.

Change Control Management:Evaluate and implement changes with Site Quality Head, Qualified Person, and QA Manager and Issue, review, and approve risk assessments for change controls.

Cleaning Validation Review: Review documentation for equipment cleaning procedures.

Document Management:Manage and distribute manufacturing procedure/master batch records and Archive executed batch records.

Process Validation Review:Review and approve documentation for manufacturing process validation.

Compliance Support:Participate in regulatory audits and support Inspection Readiness Plan.

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:

•3-6 years of work experience in API/pharmaceutical companies.

QA Manager.

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