Senior QA Specialist (inglés nivel alto imprescindible)

ALK Nordic A / S; Madrid; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a Senior Quality Assurance (QA) Specialist to enhance their Quality team. This pivotal role involves ensuring compliance with cGMP standards, overseeing QA activities, and contributing to regulatory filings. Join a dynamic environment focused on quality and continuous improvement, where your expertise will significantly impact the organization's mission.

Servicios

Collaborative work environment

Opportunities for professional development

Formación

• Minimum 5 years of QA experience in pharmaceutical/biotech industry.
• Strong knowledge of cGMP and quality systems.
• Experience with sterile product regulations and technology transfer is an asset.

Responsabilidades

• Oversee QA activities related to internal Quality Systems.
• Review technical and validation reports for manufacturing processes.
• Provide QA support for technology transfer projects.

Conocimientos

Attention to detail

Analytical thinking

Communication

Leadership

Educación

Degree in Chemistry, Pharmacy, Biology, or related field

Descripción del empleo

We are looking for a Senior Quality Assurance (QA) Specialist to join our Quality team. In this role, you will ensure that manufacturing and packaging operations adhere to cGMP requirements and that product quality meets the highest standards. You will play a key role in maintaining internal quality systems, supporting regulatory compliance, and driving continuous improvement initiatives.

Key Responsibilities

Oversee and execute QA activities related to internal Quality Systems, including change control, deviations, CAPAs, etc.

Review technical and validation reports for :

Manufacturing and packaging processes

Computer / automated systems (testing, manufacturing, materials control)

Cleaning validation and equipment cleaning procedures

Facilities and utilities with product contact

Analytical method validation

Provide QA support for technology transfer projects.

Assist with the creation and review of procedures and working instructions.

Support inspection readiness efforts and help resolve GMP issues through training and coaching.

Contribute to regulatory filings from a QA perspective.

Prepare materials for Material Review Board (MRB) meetings.

Offer QA expertise and support to cross-functional teams across the organization.

Qualifications and Requirements

Education : Degree in Chemistry, Pharmacy, Biology, or a related field.

Experience : Minimum 5 years of QA experience in the pharmaceutical / biotech industry.

Strong working knowledge of cGMP, quality systems, and regulatory compliance.

Expertise in sterile product regulations; experience with oral solid dosage forms and technology transfer is an asset.

Proficiency in pharmaceutical sciences, analytical chemistry, microbiology, and data integrity standards.

Excellent written and verbal communication skills in English.

Strong interpersonal and leadership skills; comfortable working in complex and cross-cultural environments.

Experience with Medical Devices is a plus.

Why Join Us?

This is a fantastic opportunity to join a forward-thinking organization where quality is integral to our mission. You’ll work alongside experienced professionals in a collaborative environment that values innovation, compliance, and continuous improvement.

If you're ready to make an impact and advance your career in QA, we look forward to your application.

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