Sr Associate, Quality Assurance

Alfasigma; Bologna, Milano; In loco; EUR 40.000 - 68.000; Tempo pieno

Descrizione del lavoro

Alfasigma in Italy is seeking a Quality Operation Specialist to join a 9-person team reporting to the Quality Operation Coordinator. This role will oversee investigations for deviations, complaints, and other quality events, ensuring robust root-cause analysis and CAPA implementation.

The successful candidate will coordinate cross-functional teams, monitor CAPA performance, and support GMP compliance across production activities.

Competenze

• Bachelor's degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, or related field.
• 3–4 years of pharma manufacturing experience.
• Knowledge of Fishbone Diagram, 5 Whys, and FMEA preferred.
• Fluent in English and Italian with strong technical writing.
• Experience with GMP and regulatory compliance is a plus.

Mansioni

• Lead investigations for deviations, complaints, and quality events with robust root cause identification and CAPA implementation.
• Coordinate market and customer complaint investigations and product impact assessments.
• Oversee GMP documentation and ensure SOP/CAPA closure in line with procedures.
• Support audits and regulatory inspections and drive continuous process improvement.
• Draft investigation reports and ensure action plans are executed and verified.

Conoscenze

Root cause analysis

Quality assurance

GMP

Cross-functional collaboration

Technical writing

Bilingual English/Italian

Investigation management

Formazione

Bachelor's degree in Pharmaceutical Chemistry and Technology (CTF) or related

Strumenti

TrackWise

Descrizione del lavoro

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Alfasigma 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.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. 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.

But our journey is far from complete! 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.

Responsibilities

The new employee, reporting directly to the Quality Operation Coordinator, will be part of a team of 9 people.

As a Quality Operation Specialist, 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.

Additionally, the Quality Operation Specialist will:

• Lead 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).
• Manage market and customer complaints, including product impact assessments, recurrence analysis, and coordination of investigations with internal and external stakeholders.
• Facilitate cross-functional investigation teams and ensure the timely closure of deviations, complaints, and CAPAs in accordance with internal procedures and GMP requirements.
• Monitor investigation and CAPA performance metrics and escalating quality risks when necessary.
• Draft detailed investigation reports by assessing product impact, identifying root causes, and defining corrective and preventive actions, while verifying their execution and effectiveness.
• Oversee production activities to ensure compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
• Support audits and regulatory inspections, ensuring compliance with industry standards and driving continuous process improvement.
• Contribute to periodic quality reviews through the analysis of deviations, complaints, CAPA effectiveness, and quality trends.
• Author, review, and update GMP documentation, including SOPs and Master Batch Records.
• Maintain quality records within the electronic Quality Management System (TrackWise), ensuring data accuracy, compliance, and the timely closure of assigned quality events.

Specific Skills, Educational Requirements and Experience

• Bachelor's degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, or a related scientific field.
• Minimum of 3 to 4 years of experience within a pharmaceutical manufacturing environment.
• Knowledge of investigation and root cause analysis tools, such as Fishbone Diagram, 5 Whys, and FMEA, is preferred.
• Strong command of both English and Italian; excellent technical writing skills are essential.
• Familiarity with liquid and solid oral dosage manufacturing processes would be considered an advantage.
• Strong analytical, communication, and cross-functional collaboration skills.
• Demonstrated problem-solving abilities and strong attention to detail.
• Ability to manage multiple priorities and meet deadlines in a dynamic environment.

The 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

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our 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.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.