QA Specialist: GMP/QMS Leader | Change Control & Audits

Smart4 Sciences; Almere; On-site; EUR 60,000 - 85,000; Full time

Job summary

Smart4 Sciences in Almere, Netherlands seeks a Quality Assurance Specialist to strengthen the QA team. You will own quality systems and drive continuous improvement in a GMP-regulated environment, contributing to a global business.

Responsibilities include maintaining QMS, document control, batch release support, change management, investigations, validation support, and audit readiness. A relevant degree and QA experience in regulated industries are required.

Qualifications

• Degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering or related discipline.
• Experience in QA within pharmaceuticals, excipients, medical devices, food, or other regulated industries.
• Strong knowledge of GMP, GDocP, Data Integrity (ALCOA+), and QMS processes.

Responsibilities

• Quality systems oversight: Maintain and improve the site QMS, ensuring GMP compliance.
• Document control: Review, revise, and approve SOPs, specs, and quality records for audit readiness.
• Product release: Support batch disposition by reviewing records, test results, and supplier docs.

Skills

Quality Assurance

GMP

Document control

Communication

Stakeholder management

Audit readiness

CAPA

QMS

Education

Degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering

Tools

GDocP

QMS software

CAPA tools

Job description

Smart4 Sciences in Almere, Netherlands seeks a Quality Assurance Specialist to strengthen the QA team. You will own quality systems and drive continuous improvement in a GMP-regulated environment, contributing to a global business.

Responsibilities include maintaining QMS, document control, batch release support, change management, investigations, validation support, and audit readiness. A relevant degree and QA experience in regulated industries are required.