Pharma Quality Systems Specialist – Compliance & CAPA Lead

Sire Search; Hoofddorp; On-site; EUR 54,000 - 66,000; Full time

Job summary

Sire Search is seeking a Quality Systems Specialist to support the deployment and management of the company€™s quality systems within a pharmaceutical setting. The role emphasizes compliance with GMP standards and cross-site collaboration to uphold high QA standards.

Responsibilities include overseeing Change Control, Deviations, CAPA, MRB processes, and contributing to regulatory inspections and audits, ensuring timely documentation and system improvements.

Qualifications

• 5+ years of GMP QA experience in pharma.
• Strong knowledge of GMP regs, ICHQ10, and pharma law.
• Hands-on with Change Control, CAPA, Deviations, Internal Audits.

Responsibilities

• Oversee maintenance and improvement of core quality systems (Change Control, Deviations, CAPA, MRB).
• Support site-wide regulatory compliance and quality policies.
• Chair EU Change Control Review Board, Deviations, and MRB as backup.
• Assist in inspections and audits, ensure proper documentation and cgMP adherence.
• Review and approve changes and related records.

Skills

GMP Quality Assurance

ICH Q10 knowledge

Cross-functional collaboration

MS Word/Excel/PowerPoint

Education

Bachelor's degree in technical field

Tools

Smartsheet

Power BI

Power Automate

Job description

Sire Search is seeking a Quality Systems Specialist to support the deployment and management of the company€™s quality systems within a pharmaceutical setting. The role emphasizes compliance with GMP standards and cross-site collaboration to uphold high QA standards.

Responsibilities include overseeing Change Control, Deviations, CAPA, MRB processes, and contributing to regulatory inspections and audits, ensuring timely documentation and system improvements.