GMP QA Specialist – APQR & Compliance Leader

Alk Abello Spa; Madrid; Sur place; EUR 40 000 - 60 000; Plein temps

Avantages offerts par ce poste

Professional Growth

Collaborative Culture

Competitive Benefits

Résumé du poste

ALK Abello Spa is seeking a Quality Assurance Specialist in Madrid, Spain to ensure that manufacturing and product quality align with GMP standards. The role involves performing QA activities, reviewing technical reports, and helping maintain permanent inspection readiness.

Ideal candidates should have over 3 years of experience in the pharmaceutical industry, a degree related to Chemistry, Pharmacy, or Biology, and strong English skills. ALK offers professional growth and competitive benefits.

Qualifications

• Minimum of 3 years’ experience in the pharmaceutical/biotech industry.
• Fluent in English, both written and spoken.
• Previous experience as a Qualified Person is desirable.

Responsabilités

• Perform Quality Assurance activities associated with maintaining internal Quality Systems.
• Manage APQR reports and coordinate inputs from different areas.
• Review GMP technical and validation reports for manufacturing processes.
• Provide guidance in the preparation of documented procedures.
• Support Quality Release activities including master batch records review.

Connaissances

Fluent in English

Knowledge of GMP regulations

Interpersonal and leadership skills

Experience with SAP

Understanding of sterile medicinal products

Flexibility and learning aptitude

Formation

Degree in Chemistry, Pharmacy or Biology

Description du poste

ALK Abello Spa is seeking a Quality Assurance Specialist in Madrid, Spain to ensure that manufacturing and product quality align with GMP standards. The role involves performing QA activities, reviewing technical reports, and helping maintain permanent inspection readiness.

Ideal candidates should have over 3 years of experience in the pharmaceutical industry, a degree related to Chemistry, Pharmacy, or Biology, and strong English skills. ALK offers professional growth and competitive benefits.