Quality Assurance Specialist

Exeltis; Madrid; Presencial; EUR 35.000 - 50.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits and Savings Club

Training and language learning平台

Wellness platform with psychologist

Development plans and internalMobility

Descripción de la vacante

Exeltis is seeking a Quality Assurance Specialist to ensure GxP, regulatory, and internal standards compliance across markets within the Insud Pharma group. The role involves managing quality activities for products with Exeltis Marketing Authorizations and supporting MAH in meeting local regulatory requirements.

Ideal candidates have 2+ years in QA or Quality Systems, knowledge of cGDPs/cGMPs, and fluency in English and Spanish. Travel may be required.

Formación

• University degree in pharmacy or equivalent is required.
• Fluent English and Spanish are essential.
• At least 2 years in QA or quality systems in distribution centers, affiliates, or manufacturing sites.
• Knowledge of cGDPs and cGMPs is preferred.
• Knowledge of Quality for Marketing Affiliate is desirable.
• Good command of Microsoft Office.

Responsabilidades

• Ensure compliance with GxP, regulatory, and internal standards.
• Manage quality activities for products marketed under Exeltis MAHs.
• Support handling of complaints, deviations, PQRs, recalls, and quality agreements.
• Support MAH compliance with local legislation in markets where products are marketed.
• Establish, implement, and maintain quality systems in each market.
• Provide oversight to support regulatory requirements and continuous improvement.

Conocimientos

Quality Assurance

Quality Systems

Regulatory compliance

Educación

University Degree in Pharmacy

Medium Diploma in Pharmacy

Master’s degree in Pharmaceutical Industry

Herramientas

Microsoft Office

Descripción del empleo

Experience: At least 2 years of experience in Quality Assurance or Quality Systems

Want to know more?

Exeltis is an international company committed to improving people’s health and well-being by delivering innovative, high-quality solutions in the pharmaceutical industry. As part of Insud Pharma, we are driven by excellence, innovation, and sustainable development, always placing people, quality, and regulatory compliance at the core of what we do.

At Exeltis, we are looking for a Quality Assurance Specialist to ensure compliance with GxP, regulatory, and internal standards in accordance with quality policies and applicable requirements within Insud Pharma Group.

The selected person will be involved in the management of quality activities for products commercialized in different countries under Exeltis Marketing Authorizations, supporting the MAH in complying with applicable local legislation in the markets where the products are distributed.

What are we looking for?

We are looking for a professional with experience in pharmaceutical quality assurance, a global mindset, a strong compliance focus, and the ability to coordinate quality activities in international environments.

The challenge!

• Ensure compliance with GxP, regulatory, and internal standards according to quality policies and applicable group requirements.
• Manage quality activities related to products commercialized in different countries under Exeltis MAs.
• Support the management of complaints, deviations, PQRs, recalls, quality agreements, and other key quality activities.
• Support the MAH in ensuring compliance with applicable local legislation in the countries where products are marketed.
• Ensure that appropriate quality systems are established, implemented, and maintained in each market.
• Guarantee appropriate oversight to support local regulatory requirements in a simple, compliant, and continuous improvement-oriented manner.
• Provide support to the MAH in the resolution of significant quality issues and in quality management documentation.
• Manage technical quality agreements between third parties and the MAH.
• Establish strong quality oversight of routine operations involving third parties.
• Identify quality risks and propose mitigation actions.
• Act as the key contact between the MAH and the different sites involved in the product supply chain, including manufacturers, transport companies, distributors, and other partners.
• Develop and monitor quality metrics related to third‑party organizations.
• Stay up to date with applicable regulations and promote a quality culture across the sites.
• Support the MAH in implementing the Quality digitalization strategy.
• Report directly to the Exeltis Manufacturing Quality Manager.

What do you need?

• University Degree in Pharmacy, Medium Diploma in Pharmacy, or equivalent.
• A Master’s degree in Pharmaceutical Industry will be considered a plus.
• Fluent level of English and Spanish.
• At least 2 years of experience in Quality Assurance or Quality Systems in distribution centers, affiliates, and/or manufacturing sites.
• Knowledge and experience in cGDPs and cGMPs.
• Knowledge of Quality for Marketing Affiliate.
• Knowledge of Quality Assurance, Quality Control, and/or manufacturing processes.
• Good command of Microsoft Office.
• Willingness to travel occasionally.
• Proactive attitude, energy, and ability to work under pressure.
• Problem-solving skills.
• Strong organizational skills.
• Persistent and results‑oriented mindset.

Flexible start time from Monday to Friday (full-time)

Benefits and Savings Club

Training and language learning platform

Wellness platform with unlimited free psychologist sessions

Development plans and internal mobility policy

What will the selection process be like?

• Initial contact by phone or email.
• 1 or 2 interviews with the Talent team and/or Hiring Manager.
• Ongoing communication throughout the entire process.

Do you think this opportunity is not for you?

EQUAL OPPORTUNITY COMMITMENT

At Exeltis, we are committed to fostering a diverse, inclusive, and equal opportunity workplace. All applications will be considered without regard to gender, gender identity or expression, sexual orientation, marital status, age, ethnic or social origin, nationality, religion, disability, or any other personal, physical, or social condition protected by applicable law.