Sr Associate, Quality Assurance Process Validation

Alfasigma; Alanno; In loco; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking a Senior Associate, QA Operations & Validation to ensure GMP-compliant quality operations and validation activities. You will manage process validation, documentation for product release, and collaboration with internal teams and external manufacturers.

The role emphasizes batch release support, deviation management, CAPA, and continuous improvement within a global healthcare environment, requiring a scientific degree and English fluency.

Competenze

• Degree in a scientific discipline such as Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology or Pharmaceutical Biotechnology.
• Proven experience in Quality Assurance within pharmaceutical or life sciences environments.
• Strong understanding of GMP and QA Validation activities; knowledge of process validation and CAPA.
• Experience with quality documentation review and batch release processes; proficiency with TrackWise, SAP or Veeva.

Mansioni

• Support execution and oversight of Process Validation activities and ICH Q3D requirements.
• Collect, review, and maintain quality documentation for product release, including Batch Records.
• Ensure batch documentation is complete, accurate, and compliant with regulatory standards.
• Support batch release in line with GMP, quality procedures, and Quality Agreements with manufacturers.
• Collaborate to manage deviations, quality events, and product complaints with internal and external partners.
• Participate in investigations, root cause analysis, and CAPA; follow up on action effectiveness.

Conoscenze

Quality Assurance

GMP Knowledge

Process Validation

CAPA Management

Documentation Review

Batch Release

TrackWise

SAP

Veeva

Root Cause Analysis

English Fluent

Formazione

Scientific Degree

Strumenti

TrackWise

SAP

Veeva

Quality Systems

Descrizione del lavoro

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Sr Associate, Quality Assurance Process Validation

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 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.

The 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.

Your Role

As Senior Associate, QA Operations & Validation, you will:

• Support the management and execution of Process Validation activities and ICH Q3D requirements.
• Collect, review, and maintain all quality documentation required for product release, including Batch Records and supporting GMP documentation.
• Ensure manufacturing batch documentation is complete, accurate, and compliant with applicable regulatory requirements, GMP standards, and approved product dossiers.
• Support batch release activities in accordance with GMP requirements, internal quality procedures, and Quality Agreements with third-party manufacturers and clients.
• Collaborate with internal functions, suppliers, and contract manufacturers to manage production deviations, quality events, and product complaints.
• Participate in investigations related to deviations and complaints, supporting root cause analysis and the identification of corrective and preventive actions (CAPA).
• Follow up on CAPA implementation and verify the effectiveness of actions to ensure timely and sustainable resolution of quality issues.
• Maintain accurate and compliant quality records within company quality systems.
• Support continuous improvement initiatives aimed at strengthening Quality Operations, QA Validation processes, and overall GMP compliance.
• Contribute to cross-functional projects and initiatives that support business continuity, inspection readiness, and operational excellence.

Who You Are

• Degree in a scientific discipline, preferably Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology, or Pharmaceutical Biotechnology.
• Proven experience in Quality Assurance within a pharmaceutical or life sciences environment.
• Solid understanding of GMP regulations, particularly within Quality Operations and QA Validation activities.
• Experience with quality documentation review and batch release processes.
• Knowledge of Process Validation principles and regulatory expectations.
• Familiarity with root cause analysis methodologies and CAPA management.
• Proficiency in quality and business systems such as TrackWise, SAP, Veeva, or equivalent platforms.
• Fluent in written and spoken English.
• Strong analytical and problem-solving skills, with a results-oriented approach.
• Ability to work independently while effectively managing priorities, deadlines, and multiple activities.
• High attention to detail, strong organizational skills, and proven capability in documentation management.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external partners.
• Team-oriented mindset, proactive attitude, and commitment to quality, compliance, and continuous improvement.

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.