Santhia, ITA
9 days ago
Quality Assurance Specialist (Sostituzione Maternità)
Quality Assurance Specialist (Sostituzione Maternità) Date: May 7, 2025 Location: Santhia, Italy, 0000 Company: Teva Pharmaceuticals Job Id: 61390 **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. **How you’ll spend your day** Are you someone who enjoys working in Quality Assurance? In this opportunity, the primary purpose of this role is to maintain the effectiveness of the Quality System at the Site, ensuring compliance and continuous improvement. This position reports directly to the Senior Manager, Quality Assurance & Qualified Person (QP). **The position is maternity leave cover for 12 months.** **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 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: 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. TrackWise 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 **Reports To** Senior Manager, Quality Assurance & Qualified Person (QP) **Already Working @TEVA?** If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte\_company=1080030P) 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. **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. EOE including disability/veteran
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