Quality Assurance Specialist - Villanterio (PV)

Company DescriptionAt 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 DescriptionReporting 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 ResponsibilitiesInteracts 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 archivePerforms batch documentation review prior batch release and packaging records review prior shipment in order to evaluate the compliance to internal procedureEnsures process of observing, reviewing, and auditing production operations activities in order to facilitate batch review and to assure complianceEnsures quality oversight and monitoring at shopfloor, participating to Quality Walk Around plans in production areasSupports, reviews and approves, where applicable, investigation into an event including corrective and preventive actions assuring on time closure of the investigationCollaborates with Quality Assurance Manager in reviewing effectiveness of a corrective or preventive actionIssue the Annual Product Reviews, verifying the data collectedCollaborates 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 changesCollaborates with QP and Quality Assurance Manager in Complaint ManagementParticipates 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 verificationsParticipates in review/approval of all documentation associated with manufacturing procedure / master batch cards to assure their complianceParticipates in regulatory authority and other external compliance audits. Supports Inspection Readiness Plan executionBehaves according to company Ethical Code and company valuesAssists 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 documentationSupport for archiving training documentation and periodical review of execution of annual training programUse and management of electronic Systems used in Quality DepartmentQualificationsEducation:Bachelor’s degree or Master degree in Chemistry, Pharmacy, Life Sciences or closely related discipline is requiredSkillsAble to work with a good level of autonomy with supervision where necessaryAbility to work cross-functionally.Familiar with Quality IT Systems: i.e. TrackWiseLanguages: Italian, good command of English is a strong preference.Minimum Experience / Training RequiredAt least two years work experience in Quality or related field experience is required. Preferred experience in the API Industry.Additional InformationWhat We OfferWe strive to be attentive to our employees, offering them both small and significant benefits. By way of example: 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 programsTAPI’s Commitment to Equal OpportunitiesTAPI 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 TAPIYour 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!