Sr Associate, Quality Assurance Process Validation
Pubblicato il 08-10-2026 - ALFASIGMA in Alanno
pSelect how often (in days) to receive an alert: /p h3Sr Associate, Quality Assurance Process Validation /h3 pAlfasigma 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. /p pOver 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. /p pbBut 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. /p h3Scope of the Role /h3 pThe Senior Associate, QA Operations Validation supports the execution, oversight, and continuous improvement of Quality Operations and QA Validation activities, ensuring full compliance with GMP requirements, internal procedures, regulatory expectations, and Quality Agreements with external manufacturing partners. /p pThe role is responsible for supporting Process Validation and ICH Q3D-related activities, managing quality documentation associated with batch release, and contributing to the effective management of quality events. This position plays a critical role in ensuring the continuity of QA activities related to batch release, product quality, and regulatory compliance while collaborating with internal stakeholders and external manufacturers. /p h3Your Role /h3 pAs Senior Associate, QA Operations Validation, you will: /p ul liSupport the management and execution of Process Validation activities and ICH Q3D requirements.
/li liCollect, review, and maintain all quality documentation required for product release, including Batch Records and supporting GMP documentation. /li liEnsure manufacturing batch documentation is complete, accurate, and compliant with applicable regulatory requirements, GMP standards, and approved product dossiers. /li liSupport batch release activities in accordance with GMP requirements, internal quality procedures, and Quality Agreements with third-party manufacturers and clients. /li liCollaborate with internal functions, suppliers, and contract manufacturers to manage production deviations, quality events, and product complaints. /li liParticipate in investigations related to deviations and complaints, supporting root cause analysis and the identification of corrective and preventive actions (CAPA). /li liFollow up on CAPA implementation and verify the effectiveness of actions to ensure timely and sustainable resolution of quality issues. /li liMaintain accurate and compliant quality records within company quality systems. /li liSupport continuous improvement initiatives aimed at strengthening Quality Operations, QA Validation processes, and overall GMP compliance. /li liContribute to cross-functional projects and initiatives that support business continuity, inspection readiness, and operational excellence. /li /ul h3Who You Are /h3 ul liDegree in a scientific discipline, preferably Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology, or Pharmaceutical Biotechnology. /li liProven experience in Quality Assurance within a pharmaceutical or life sciences environment. /li liSolid understanding of GMP regulations,
particularly within Quality Operations and QA Validation activities. /li liExperience with quality documentation review and batch release processes. /li liKnowledge of Process Validation principles and regulatory expectations. /li liFamiliarity with root cause analysis methodologies and CAPA management. /li liProficiency in quality and business systems such as TrackWise, SAP, Veeva, or equivalent platforms. /li liFluent in written and spoken English. /li liStrong analytical and problem-solving skills, with a results-oriented approach. /li liAbility to work independently while effectively managing priorities, deadlines, and multiple activities. /li liHigh attention to detail, strong organizational skills, and proven capability in documentation management. /li liExcellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external partners. /li liTeam-oriented mindset, proactive attitude, and commitment to quality, compliance, and continuous improvement. /li /ul pThe 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 /p h3Why Join Alfasigma: /h3 h3At Alfasigma, we foster a culture where the courage to innovate is key to our success. /h3 pWe offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. /p pOur 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. /p h3Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry. /h3 #J-18808-Ljbffr