Qualified Person (QP)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/87936h

h3Job Description Summary /h3pSalary Range: €43,800.00 - €81,300.00 Band Level 4 /ppLocation: Colleretto Giacosa (Ivrea), Italy. This role is based in Ivrea, Italy. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. /ppWe are seeking a highly qualified and independent Qualified Person to oversee and ensure the compliance of manufacturing and quality control activities at the site, in accordance with the applicable drug manufacturing license and local regulatory requirements. In this role, the Qualified Person will independently supervise manufacturing processes and control testing activities, acting in full compliance with Article 52 of Legislative Decree No. 219 of April 24, 2006, derived from EU Directive 2001/83/EC, and subsequent amendments. The role is critical in ensuring that medicinal products meet the required standards of quality, safety, and regulatory compliance. /ppWorking closely with the Site Quality Head and Site Manager, the successful candidate will support the effective implementation, monitoring, and continuous maintenance of a GMP-compliant Quality Management System. This includes ensuring adherence to national medicines legislation, applicable regulations, internal ADACAP quality standards, approved product quality requirements, and site SOPs. /ppAs part of the Quality Assurance function, the role will provide both operational and strategic support for GMP-related activities, helping to identify, manage, and resolve quality issues while promoting a culture of compliance, accountability, and continuous improvement across the site. /ph3Major Accountabilities /h3ulliCertify and release medicinal product batches, ensuring manufacturing and testing are performed in compliance with applicable laws, GMP requirements, and Marketing Authorization conditions. /liliEnsure batch documentation and records are complete, accurate, properly stored, and available for inspection or upon request by Health Authorities. /liliAssess and release manufactured medicinal products in accordance with national legislation and Qualified Person responsibilities.



/liliCollaborate with Quality Control and Production teams to support batch-related activities and ensure smooth, compliant production operations. /liliReview, support, and approve quality processes including deviations, complaints, change controls, CAPAs, and related investigations. /liliImmediately escalation any significant quality irregularities identified in marketed products to site management and the Italian Medicines Agency, AIFA, as required. /liliPartner with functional leaders to maintain, monitor, and continuously improve an effective GMP-compliant Quality Management System. /liliIdentify and propose technological, procedural, and organizational improvements to enhance quality, productivity, cost efficiency, and resource optimization. /li /ulh3Obligatory Requirements /h3ulliDegree in Pharmacy, Pharmaceutical Chemistry and Technology, CTF, Chemistry, or a related scientific discipline. /liliPrevious experience as a Qualified Person within a pharmaceutical sterile manufacturing environment. /liliQualification as an Authorized Qualified Person, in accordance with Legislative Decree No. 219 of April 24, 2006. /liliStrong understanding of GMP requirements, pharmaceutical quality systems, and regulatory expectations. /liliHigh level of quality awareness, with a proactive approach to identifying and resolving compliance-related issues. /liliExcellent collaboration and communication skills, with the ability to work effectively across Quality Control, Production, and site leadership teams. /liliAbility to support daily production operations while ensuring compliance, safety, and product quality. /liliFluency in Italian and English, both written and spoken.



/li /ulh3Rewards /h3pWe also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave. /ppExpected Annual Base Salary Range for role: EUR 43,800-81,300. The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based premio depending on certain performance parameters. Further details will be provided during the application process. /ppPay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: /ph3Commitment to Diversity and Inclusion / EEO paragraph /h3pNovartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve. /ph3Why Novartis /h3pHelping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? /ph3Benefits and Rewards /h3pRead our handbook to learn about all the ways we’ll help you thrive personally and professionally: /ph3Skills Desired /h3pImproving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/87936h