Quality Assurance Specialist - Villanterio (PV)

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. Job Description Reporting to the QA Manager inside of the Quality team the person assure the compliance of batches in order to establish a disposition decision of release or rejection, including quality oversight and monitoring on the shopfloor. Main Activities And Responsibilities Interacts effectively with employees; manager and cross-functional peers. May represent QA team while on cross-functional project teams. Performs quality documentation activities: issuance of GMP documentation and logbooks, update the SOP archive Performs batch documentation review prior batch release and packaging records review prior shipment in order to evaluate the compliance to internal procedure Ensures process of observing, reviewing, and auditing production operations activities in order to facilitate batch review and to assure compliance Ensures quality oversight and monitoring at shopfloor, participating to Quality Walk Around plans in production areas Supports, reviews and approves, where applicable, investigation into an event including corrective and preventive actions assuring on time closure of the investigation Collaborates with Quality Assurance Manager in reviewing effectiveness of a corrective or preventive action Issue the Annual Product Reviews, verifying the data collected Collaborates with QP, Quality Assurance Manager and Compliance in processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow (including but not limited to SOPs, production batch and cleaning records, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc). Collaborates with Quality Assurance Manager and QP in the oversight of implementation of required changes Collaborates with QP and Quality Assurance Manager in Complaint Management Participates in review/approval of all documentation associated with the validation of the procedure(s) used to clean the equipment train for a product’s manufacturing and packaging process and cleaning verifications Participates in review/approval of all documentation associated with manufacturing procedure / master batch cards to assure their compliance Participates in regulatory authority and other external compliance audits. Supports Inspection Readiness Plan execution Behaves according to company Ethical Code and company values Assists the Qualified Person of the site and collaborates with the QP in the performance of the function (DL. 219/06 art. 52 paragraph 10 and art. 64 paragraph 3) Collaborates with the Regulatory Affairs function, with SQH and with the Qualified Persons, to ensure conformity, completeness and correspondence of the regulatory documentation Support for archiving training documentation and periodical review of execution of annual training program Use and management of electronic Systems used in Quality Department Qualifications Education Bachelor’s degree or Master degree in Chemistry, Pharmacy, Life Sciences or closely related discipline is required 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, good command of English is a strong preference. Minimum Experience / Training Required At least two years work experience in Quality or related field experience is required. Preferred experience in the API Industry. What We Offer Ticket restaurant 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 Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon! J-18808-Ljbffr

Location: Villanterio, Lombardia, IT

Posted Date: 11/17/2025