Quality Assurance / Qualified Person (QP)

ALK; Madrid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

ALK is seeking a Quality Assurance / Qualified Person (QP) to ensure compliance with cGMP regulations and maintain the highest standards of product quality. This role involves hands-on responsibilities in batch record review and active participation in training and audits. Join a dedicated team in a global pharmaceutical environment focused on delivering life-saving treatments.

Servicios

Professional development opportunities

Collaborative environment

Global impact on patient safety

Formación

• Minimum 3 years’ experience in pharmaceutical or biotech industries.
• Proven experience as a Qualified Person (QP).
• In-depth knowledge of EU GMPs and quality systems.

Responsabilidades

• Overseeing batch review and product release processes.
• Participating in compliance audits and quality-related processes.
• Contributing to cGMP training programs.

Conocimientos

Attention to detail

Effective communication

Quality mindset

Leadership

Educación

University degree in Pharmacy

Herramientas

Microsoft Office

SAP systems

Descripción del empleo

Quality Assurance / Qualified Person (QP)

Join to apply for the Quality Assurance / Qualified Person (QP) role at ALK

Quality Assurance / Qualified Person (QP)

Join to apply for the Quality Assurance / Qualified Person (QP) role at ALK

Get AI-powered advice on this job and more exclusive features.

Are you ready to ensure the highest standards of product quality in a global pharmaceutical environment? ALK is seeking a dedicated and detail-oriented Quality Assurance / Qualified Person (QP) to join our Quality team. In this vital role, you will be responsible for overseeing key Quality Assurance (QA) functions, ensuring that manufacturing and packaging operations—both in-house and at contract manufacturing organizations (CMOs)—comply with cGMP regulations. Your work will directly support our mission of delivering high-quality, life-saving treatments to patients worldwide.

This position combines hands-on batch record review and product release with strategic involvement in continuous improvement, training, audits, and global projects. If you are passionate about compliance, quality, and teamwork, we invite you to be part of our collaborative and purpose-driven organization.

Key Responsibilities :

• Batch Review & Release :
• Review batch records for completeness and accuracy
• Approve Master Batch Records for manufacturing and packaging
• Disposition and release products manufactured in-house or by third-party CMOs, including new product introductions
• Compliance & Quality Oversight :
• Participate in and support internal and external (supplier) GMP audits
• Support quality-related processes such as change control, deviations, CAPA, and customer complaints
• Support the preparation and approval of Product Quality Reviews (PQRs)
• Training & Support :
• Contribute to the execution and development of cGMP training programs
• Provide guidance and support to cross-functional teams in managing quality-impacting situations
• Participate in global quality initiatives and projects as needed

Qualifications :

• Educational Background :
• University degree in Pharmacy (required)
• Advanced understanding of GMP regulations and pharmaceutical quality systems
• Professional Experience :
• Minimum 3 years’ experience in pharmaceutical or biotech industries
• Proven experience as a Qualified Person (QP)
• In-depth knowledge of EU GMPs, quality systems, and regulatory frameworks
• Technical & Language Skills :
• Proficient in Microsoft Office and SAP systems
• Fluent in English, both written and spoken
• Personal Attributes :
• Strong quality mindset and attention to detail
• Capable of detecting issues and driving continuous improvement
• Effective communication and leadership skills, especially in cross-cultural environments
• Resilient and comfortable managing complexity and ambiguity in a regulated setting

Why ALK?

• Global Impact : Play a key role in ensuring product quality for a global leader in allergen immunotherapy
• High-Standards Culture : Work in a company where quality is central to everything we do
• Collaborative Environment : Join a team of professionals passionate about patient safety and continuous improvement
• Professional Development : Opportunity to engage in global projects and expand your pharmaceutical quality expertise

Ready to Safeguard Patient Trust?

If you’re an experienced Qualified Person looking to make a meaningful impact in a patient-focused organization, apply now and become part of our mission at ALK.

Seniority level

• Seniority level Not Applicable

Employment type

• Employment type Full-time

Job function

• Job function Quality Assurance
• Industries Pharmaceutical Manufacturing

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