Senior QA Specialist (inglés nivel alto imprescindible)

Job title:

Senior QA Specialist (inglés nivel alto imprescindible)

Company:

ALK-Abelló

Job description

About the RoleWe 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 ResponsibilitiesOversee and execute QA activities related to internal Quality Systems, including change control, deviations, CAPAs, etc.Review technical and validation reports for:Manufacturing and packaging processesComputer/automated systems (testing, manufacturing, materials control)Cleaning validation and equipment cleaning proceduresLaboratory/manufacturing equipment qualificationFacilities and utilities with product contactAnalytical method validationProvide 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 RequirementsEducation: 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.Send applicationShare on:Region:

• Comunidad de Madrid

Location:Madrid, SpainCompany homepage:Office address:Calle Miguel Fleta 19, 28037 MadridOffice location:ALK-Abelló A/SALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy.
ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen.
We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.

Expected salary

Location

Madrid

Job date

Fri, 23 May 2025 07:05:27 GMT

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