Sr Associate, Quality Assurance

ppSelect how often (in days) to receive an alert: /ppAlfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. /ppOver three years ago, we embarked on a transformative journey to become ba truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health /b. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. /ppbBut our journey is far from complete! /b In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets. /ph3Responsibilities /h3pThe new employee, reporting directly to the bQuality Operation Coordinator /b, will be part of a team of 9 people. /ppAs a bQuality Operation Specialist /b, he/she will play a crucial role in conducting investigations related to deviations, complaints, and other quality events. Working closely with Quality Assurance and other internal and external stakeholders, he/she will be responsible for overseeing production activities, verifying on the shop floor the accurate completion of Batch Record Reviews, logbooks, and other GMP documentation, identifying root causes, ensuring the implementation of corrective and preventive actions, and supporting regulatory compliance. /ppAdditionally, the Quality Operation Specialist will: /pulliLead and coordinate investigations for deviations, complaints, and quality events, ensuring robust root cause identification, risk assessment, and implementation of effective corrective and preventive actions (CAPAs). /liliManage market and customer complaints, including product impact assessments, recurrence analysis, and coordination of investigations with internal and external stakeholders. /liliFacilitate cross-functional investigation teams and ensure the timely closure of deviations, complaints, and CAPAs in accordance with internal procedures and GMP requirements. /liliMonitor investigation and CAPA performance metrics and escalating quality risks when necessary. /liliDraft detailed investigation reports by assessing product impact, identifying root causes, and defining corrective and preventive actions, while verifying their execution and effectiveness. /liliOversee production activities to ensure compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). /liliSupport audits and regulatory inspections, ensuring compliance with industry standards and driving continuous process improvement. /liliContribute to periodic quality reviews through the analysis of deviations, complaints, CAPA effectiveness, and quality trends. /liliAuthor, review, and update GMP documentation, including SOPs and Master Batch Records. /liliMaintain quality records within the electronic Quality Management System (TrackWise), ensuring data accuracy, compliance, and the timely closure of assigned quality events. /li /ulh3Specific Skills, Educational Requirements and Experience /h3ulliBachelor's degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, or a related scientific field. /liliMinimum of 3 to 4 years of experience within a pharmaceutical manufacturing environment. /liliKnowledge of investigation and root cause analysis tools, such as Fishbone Diagram, 5 Whys, and FMEA, is preferred. /liliStrong command of both English and Italian; excellent technical writing skills are essential. /liliFamiliarity with liquid and solid oral dosage manufacturing processes would be considered an advantage. /liliStrong analytical, communication, and cross-functional collaboration skills. /liliDemonstrated problem-solving abilities and strong attention to detail. /liliAbility to manage multiple priorities and meet deadlines in a dynamic environment. /li /ulpThe compensation range indicated in this job posting represents an estimated average range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements /ppbWhy Join Alfasigma: /b /ppbAt Alfasigma, we foster a culture where the courage to innovate is key to our success. /bbr/We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. /ppOur commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. /ppbJoin Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry. /b /p /p #J-18808-Ljbffr