Quality Assurance Specialist

Novo Nordisk A/S; Madrid; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Quality Assurance Specialist to uphold the highest quality standards in their Madrid office. In this pivotal role, you will enhance the Quality Management System while collaborating with the QA Head. Your expertise in Good Distribution Practice (GDP) compliance and quality assurance will be crucial in managing audits and inspections, ensuring adherence to both internal and external standards. Join a dynamic team dedicated to continuous improvement and excellence, where your contributions will have a meaningful impact on delivering life-changing products to patients worldwide.

Formación

• 3+ years of experience in QA within the pharmaceutical industry.
• Strong knowledge of GDP regulations and quality management systems.

Responsabilidades

• Maintain and improve the Quality Management System (QMS).
• Oversee audits and inspections, ensuring GDP compliance.

Conocimientos

Quality Assurance

Good Distribution Practice (GDP)

Problem-solving

Attention to detail

Communication skills

Negotiation skills

Educación

Degree in Pharmacy

Degree in Health Sciences

Related field degree

Herramientas

Quality Management Systems

Documentation Management

Change Control Management

Descripción del empleo

Are you passionate about ensuring the highest quality standards? Do you have experience in quality assurance and GDP for pharmaceutical products? If so, we have an exciting opportunity for you as a Quality Assurance (QA) Specialist in our Madrid office. Read more and apply today for a life-changing career.

The position

As a QA Specialist, you will maintain and improve our Quality Management System (QMS), collaborating with the QA Head to provide raw data for periodic Quality Management Reviews (QMR), identifying and mitigating risk via Quality Risk Management (QRM).

You will play a key role in supporting the following main QMS systems:

• Deviation handling
• Change control management and CAPA management
• Documentation management and training management
• Validation and qualification management
• Data integrity management
• Supplier and client management

You will oversee the management of audits and inspections, serving as a key liaison in supporting Novo Nordisk during GDP / GMP inspections conducted by regulatory authorities. Furthermore, you will support the organization during internal corporate GDP / GMP audits and ensure smooth audit management processes. Additionally, you will be responsible for maintaining strict GDP compliance, ensuring that all standards and procedures align with internal and external requirements and industry best practices, while working with other affiliate departments to improve and maintain the quality management system for the Novo Nordisk affiliate and support the local QA team.

Qualifications

The ideal candidate has a degree in Pharmacy, Health Sciences, or a related field, complemented by substantial experience in QA tasks, specifically within the scope of Good Distribution Practice (GDP) compliance.

On top of what we would expect:

• Proven experience of minimum 3 years in QA within the pharmaceutical industry.
• Knowledge and experience with Quality and Quality Management systems.
• Experience with GDP regulation and activities.
• Excellent problem-solving skills and attention to detail.
• Strong communication and negotiation skills.

About the department

Our Quality department in Madrid is dedicated to ensuring the highest standards of quality across our value chain. We are a dynamic and collaborative team, committed to continuous improvement and excellence in everything we do. With a focus on compliance, risk assessment, and quality assurance, we play a critical role in delivering life-changing products to patients around the world.