TAPI - Senior Quality Assurance Specialist
Caronno Pertusella, Italy, 21042
Who we are
TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.
The opportunity
Are you passionate about ensuring products meet the highest standards? Do you have an eye for detail and a knack for identifying potential issues before they become problems? Imagine being one of the key players who contributes to guarantee that every product released is flawless and reliable.
Reporting to the Quality Assurance Manager, you will contribute to maintaining the effectiveness of the Quality System at the site.
How you’ll spend your day
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 Customer Service: Prepare responses to customer requests, verify documentation, and set due dates with Customer Service.
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.
Ethical Conduct: Behave according to company Ethical Code and values, support employee motivation and development.
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. TrackWise
Languages:
• Italian, proficient English
Minimum Experience / Training required:
•3-6 years of work experience in API/pharmaceutical companies.
Reports To
QA Manager.
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