TAPI - Senior Quality Assurance Specialist

TAPI - Senior Quality Assurance Specialist Date: Apr 10, 2025 Location: Caronno Pertusella, Italy, 21042 Job Id: 61481 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, enabling TAPI to lead the industry based on our experience, expertise, technologies, and exceptional customer service. Our employees are at the core of our success. Headquartered 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; issue and review complaint reports, notify suppliers of complaints. Deviations: Investigate deviations with Site Quality Head, Qualified Person, and QA Manager; 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; 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. Minimum Experience / Training required: 3-6 years of work experience in API/pharmaceutical companies. Reports To QA Manager. Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. J-18808-Ljbffr

Location: caronno-pertusella, IT

Posted Date: 4/19/2025