Quality Assurance Specialist Qualified Person (QP)

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

Company

A leading organization in the pharmaceutical industry dedicated to ensuring the highest quality standards in manufacturing and product development. The company operates under strict regulatory guidelines and values excellence, compliance, and continuous improvement.

Role Description

We are looking for an experienced Quality Assurance Specialist Qualified Person (QP) to oversee and ensure the quality and regulatory compliance of pharmaceutical products. This role involves coordinating product release, managing quality investigations, and supporting inspections and audits to uphold the company’s high standards in production.

Responsibilities

• Review and approve master documents and specifications to ensure compliance
• Initiate and evaluate quality investigations, making release or rejection decisions, and implementing improvement actions
• Complete deviation and investigation reports promptly and accurately
• Lead quality improvement initiatives to mitigate risks in production processes
• Authorize ongoing stability studies and product quality reviews
• Prepare for and manage inspections by government agencies and customers, including self-inspections and participation in overseas audits
• Handle product complaints, investigate causes, and coordinate recalls when necessary
• Maintain communication with external regulators, clients, and partners
• Support technology transfer activities and ensure smooth knowledge transfer processes
• Provide functional leadership to QA team members, including planning, structuring, and training staff

Requirements

• Degree in pharmacy, chemistry, biology, or a related field (per art 49 paragraph 2 directive 2001/83/EC)
• Over 5 years of experience in aseptic production, with knowledge of lyophilization and visual inspection preferred
• Strong understanding of pharmaceutical laws and regulations (EU and US)
• Proficiency in analytical methods and automated processes
• Decisive, results-oriented, and transparent communicators with a proactive approach

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