Quality Assurance Qualified Person (QP) — Product Release Expert

SIRE LIFE SCIENCES; Haarlem; On-site; EUR 70,000 - 110,000; Full time

Job summary

SIRE LIFE SCIENCES seeks an experienced Quality Assurance Specialist Qualified Person (QP) to oversee quality and regulatory compliance of pharmaceutical products in the Netherlands. You will coordinate product release, manage investigations, and support inspections and audits to uphold high standards.

Responsibilities include leading deviation handling, reviewing master documents, and ensuring adherence to EU/US regulations. Strong analytical and proactive communication skills are essential.

Qualifications

• Degree in pharmacy, chemistry, biology, or a related field.
• Over 5 years of aseptic production experience.
• Strong understanding of pharmaceutical laws and regulations (EU and US).
• Proficiency in analytical methods and automated processes.

Responsibilities

• Review and approve master documents and specifications for compliance.
• Initiate and evaluate quality investigations and decide release or rejection.
• Complete deviation and investigation reports promptly.
• Lead quality improvement initiatives to mitigate production risks.
• Authorize ongoing stability studies and product quality reviews.
• Prepare for and manage inspections by authorities and customers.
• Handle product complaints and coordinate recalls when necessary.
• Maintain communication with regulators, clients, and partners.
• Support tech transfer activities and ensure knowledge transfer.
• Provide leadership to QA team, including planning and training staff.

Skills

Regulatory knowledge

Quality Assurance

Analytical methods

Automated processes

Education

Degree in pharmacy, chemistry, biology, or related field

Job description

SIRE LIFE SCIENCES seeks an experienced Quality Assurance Specialist Qualified Person (QP) to oversee quality and regulatory compliance of pharmaceutical products in the Netherlands. You will coordinate product release, manage investigations, and support inspections and audits to uphold high standards.

Responsibilities include leading deviation handling, reviewing master documents, and ensuring adherence to EU/US regulations. Strong analytical and proactive communication skills are essential.