Company Description At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we’re shaping the future of health worldwide. Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives. 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. MAIN ACTIVITIES AND RESPONSIBILITIES: 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. 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: - 1-2 years of work experience in API/pharmaceutical companies. Additional Information What We Offer We strive to be attentive to our employees, offering them both small and significant benefits. By way of example: - Canteen - Recognition Program - Welfare Platform - Coffee token - Health insurance with access to top medical centers - Inclusive and multicultural work environment - Ongoing learning and professional development programs TAPI’s Commitment to Equal Opportunities TAPI is committed to ensuring equal opportunities in the workplace. Our global policy provides that employment opportunities are offered regardless of age, race, religion, health status, identity, gender expression, protected categories, or any other legally recognized status entitled to protection under applicable laws. Make Your Mark with TAPI