In the quality department based in Rho, manages the site Quality Assurance system and supports the Site Quality Head in activities related to the Site Quality Program, promoting Quality Culture and Operational Excellence. Manage the Quality Assurance team. As Deputy QP, responsible for the release of Active Pharmaceutical Ingredients (APIs) in compliance with Italian legislation and international cGMP standards (according to the SOP R-QA001). Ensures the full definition, implementation, and management of quality and safety systems for APIs produced at the site, in accordance with applicable laws and standards (DL 219 / 2006 art. 52 and art. 64, updated by DL of February 19, 2014). Major Activities : Acts in accordance with the company’s Code of Ethics and values. Reviews and approves executed batch records for intermediates and finished products. Ensures compliance with Italian and EU laws for the production and release of APIs. Collaborates with Compliance for customer audits and supports the Site Quality Head in managing authority inspections. Works with Regulatory Affairs to ensure regulatory documentation is complete and compliant. Supports and oversees the internal audit program and the implementation of corrective actions. Manages corrective actions from external inspections (authorities, customers, etc.). Supports the Change Control system; reviews, approves, and closes change controls. Evaluates and approves analytical investigations for out-of-specification (OOS) results. Investigates, reviews, and approves deviations; coordinates deviation and non-conformity management. Manages customer complaints, including investigations, corrective actions, responses, and closure. Plans training activities for QA staff. Oversees the preparation of Annual Product Reviews. Supports all activities required to maintain the validated state of manufacturing processes. Reviews and approves the Validation Master Plan and related documentation. Contributes to tracking, trending, and reporting of site Quality Metrics. Ensures motivation and development of QA employees in line with HR policies. Safety Responsibility : Acts as “Preposto per la sicurezza” under Italian Law D.lgs 81 / 2008 : supervises work and ensures implementation of safety directives. Key Responsibilities : Deviation, OOS / OOT / LIR and CAPA Management Change control and complaints management Annual Product Review management Ensure release planning in collaboration with Quality Control and Supply Chain GMP supervision on the shop floor Support process optimization Collaborate with cross-functional teams (Regulatory, Quality Control, MS&T, Production) to ensure full GMP and regulatory compliance Qualifications Required Education : University degree as per legal requirements, preferably in Chemistry or Pharmaceutical Chemistry and Technology (CTF) A Master’s degree or additional training in Quality Assurance or Regulatory Affairs is preferred Authorization by AIFA as Qualified Person is mandatory Professional Experience : At least 5 years of experience in Quality Assurance and Quality Control Skills : Strong understanding of GMP requirements for investigational and development activities Experience with investigation techniques (e.g., root cause analysis) and CAPA system management CDMO / CMO experience is preferred Ability to work cross-functionally Strong change management capabilities Familiarity with Quality IT Systems (e.g., TrackWise) Experience in inspection management Management and leadership skills Languages : 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 Policies for caregivers and parents with flexible work arrangements 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