Quality Assurance Specialist

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

Quality Assurance Specialist – Almere – Onsite

A leading pharmaceutical excipient manufacturer in Almere is seeking a Quality Assurance Specialist to strengthen its QA team. This is an excellent opportunity for someone with experience in GMP‑regulated environments to take ownership of quality systems and contribute to continuous improvement within a global business.

Key Responsibilities

• Quality systems oversight: Maintain and improve the site QMS, ensuring compliance with GMP, EXCiPACT, ISO 9001, and customer requirements.
• Document control: Review, revise, and approve SOPs, specifications, and quality records, keeping documentation accurate and audit‑ready.
• Product release: Support batch disposition by reviewing records, test results, and supplier documentation to ensure compliance before release.
• Change management: Coordinate site change controls, impact assessments, and approvals, ensuring effective implementation and closure.
• Investigations: Lead deviation, non‑conformance, and supplier quality investigations, driving root cause analysis and CAPA activities.
• Validation support: Coordinate validation protocols, reports, and documentation, ensuring timely execution and compliance.
• Audit readiness: Maintain inspection readiness, support internal/external audits, and promote a culture of compliance and continuous improvement.

Requirements

• 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.
• Experience with document control systems, audits, validation, and CAPA management.
• Excellent communication, organizational, and stakeholder management skills.