Associate, Quality Assurance - Temporary Maternity Leave Replacement

Alfasigma; Bologna; Remoto; EUR 35.000 - 52.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking an Associate, Quality Assurance to support GMP-compliant quality system activities at the Alanno site, focusing on CAPA closures and management of Quality Agreements with customers involved in third-party manufacturing. The role emphasizes collaboration with global affiliates and cross-functional teams.

The ideal candidate holds a science degree and demonstrates fluent English, strong GMP knowledge, and experience with TrackWise, SAP, and Veeva.

Competenze

• You have a solid understanding of GMP regulations, particularly in relation to Quality Systems, together with proven experience in Quality Assurance.
• You are fluent in written and spoken English.
• You are proficient in IT tools and quality systems, such as TrackWise, SAP, and Veeva.
• You bring strong analytical and problem-solving skills, combined with a results-oriented mindset.
• You are able to work independently and effectively manage priorities and deadlines.
• You are detail-oriented, organized, and skilled in document management.
• You have excellent communication and teamwork skills, with the ability to collaborate across departments and contribute to group objectives.

Mansioni

• Manage Quality Agreements with customers for third-party manufacturing activities, ensuring consistency, compliance, and alignment with agreed expectations and global affiliate requirements.
• Support the management and timely closure of Corrective and Preventive Actions (CAPAs).
• Coordinate and monitor change control activities within the Alanno environment.
• Ensure that Quality System activities are performed in accordance with GMP requirements, internal procedures, and business priorities.
• Maintain accurate, complete, and well-organized quality documentation.
• Collaborate effectively with cross-functional departments, customers, and global affiliates to support shared quality objectives.
• Monitor priorities and deadlines, proactively identifying issues and supporting effective solutions.

Conoscenze

Analytical and problem-solving

Communication skills

Teamwork

Formazione

A degree in a scientific discipline such as Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology, or Pharmaceutical Biotechnology

Strumenti

TrackWise

SAP

Veeva

Descrizione del lavoro

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Associate, Quality Assurance - Temporary Maternity Leave Replacement

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.

Scope of the Role

The role supports the management of Quality System activities within the Alanno site, contributing to the timely closure of CAPAs and change actions to ensure compliance with GMP requirements and business needs. In parallel, the position is responsible for the effective management of Quality Agreements with customers relating to third-party manufacturing activities, ensuring consistency, regulatory compliance, and alignment with customer expectations and global affiliates.

Your Role

• Manage Quality Agreements with customers for third-party manufacturing activities, ensuring consistency, compliance, and alignment with agreed expectations and global affiliate requirements.
• Support the management and timely closure of Corrective and Preventive Actions (CAPAs).
• Coordinate and monitor change control activities within the Alanno environment.
• Ensure that Quality System activities are performed in accordance with GMP requirements, internal procedures, and business priorities.
• Maintain accurate, complete, and well-organized quality documentation.
• Collaborate effectively with cross-functional departments, customers, and global affiliates to support shared quality objectives.
• Monitor priorities and deadlines, proactively identifying issues and supporting effective solutions.

Who You Are

• You hold a degree in a scientific discipline, such as Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology, or Pharmaceutical Biotechnology.
• You have a solid understanding of GMP regulations, particularly in relation to Quality Systems, together with proven experience in Quality Assurance.
• You are fluent in written and spoken English.
• You are proficient in IT tools and quality systems, such as TrackWise, SAP, and Veeva.
• You bring strong analytical and problem-solving skills, combined with a results-oriented mindset.
• You are able to work independently and effectively manage priorities and deadlines.
• You are detail-oriented, organized, and skilled in document management.
• You have excellent communication and teamwork skills, with the ability to collaborate across departments and contribute to group objectives.

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.