GMP Quality & Compliance Specialist — CAPA & Deviation Lead

Sire Search; Haarlem; On-site; EUR 60,000 - 85,000; Full time

Job summary

Sire Search seeks a Quality & Compliance Specialist to support day-to-day production in Haarlem, working on deviations, investigations, CAPA follow-up, and documentation improvements to meet GMP standards.

You'll collaborate with production and quality teams, review SOPs and batch records, and ensure compliant records, investigations, and audit responses. Strong English skills and a Master’s level related degree are required.

Qualifications

• Master’s level degree in Pharmacy, Chemical Engineering, or related field.
• Experience in pharmaceutical production environments.
• Strong knowledge of QA systems and GMP documentation.
• Experience with deviation management, investigations, CAPA.
• Strong written and spoken English.
• Temporary 3-month full-time contract.

Responsibilities

• Support manufacturing and packaging teams with deviations and quality-related questions.
• Assess deviations and advise whether production activities should be paused or stopped when needed.
• Monitor production processes and identify deviations from established procedures.
• Investigate and document deviations and complaints, ensuring clear, compliant records.
• Perform and document root cause investigations and drive CAPA actions to closure.
• Propose and support improvements to production methods, processes, and product quality.
• Contribute to continuous improvement initiatives, including actions from audits.
• Review and support updates to SOPs, batch records, and related documentation.
• Ensure quality standards and GMP instructions are implemented and maintained in production.
• Support compliance investigations and audit responses where required.
• Provide knowledge transfer and deliver training to stakeholders.
• Participate in operational and quality meetings with key internal stakeholders.

Skills

Deviation management

CAPA

Root cause analysis

Quality assurance

GMP documentation

Stakeholder management

English communication

Education

Master’s degree in Pharmacy or related field

Tools

Documentation control tools

Job description

Sire Search seeks a Quality & Compliance Specialist to support day-to-day production in Haarlem, working on deviations, investigations, CAPA follow-up, and documentation improvements to meet GMP standards.

You'll collaborate with production and quality teams, review SOPs and batch records, and ensure compliant records, investigations, and audit responses. Strong English skills and a Master’s level related degree are required.