Quality Assurance Specialist – Deviation Management

Sire Search; Haarlem; On-site; EUR 70,000 - 90,000; Full time

Job summary

Sire Search is seeking a Senior Quality Assurance Specialist to join our pharmaceutical quality team. You will focus on reducing the backlog of deviation investigations, with emphasis on deviation handling and writing, collaborating with production and the QP team to ensure compliance without participating in batch release.

The ideal candidate has at least five years of QA experience in pharma, strong aseptic manufacturing and lyophilization exposure, and solid knowledge of EU and US

Qualifications

• Minimum 5 years of experience in pharmaceutical quality assurance, with strong exposure to aseptic manufacturing and lyophilization.
• Proven experience in deviation handling and investigation.
• Solid understanding of aseptic processes and visual inspection of lyophilized products.
• Good knowledge of pharmaceutical regulations (EU and US) and analytical methods.
• Excellent command of English, especially for technical documentation.
• Dutch language skills are a plus but not mandatory.
• Experience with automated processes is preferred.
• Strong problem-solving and decision-making skills with a result-oriented approach.

Responsibilities

• Manage and resolve deviation reports, including investigating, writing, and documenting deviations.
• Support the QA department in reducing deviation backlog and implementing quality improvements.
• Review and approve master documents and specifications for product release.
• Initiate and assess quality investigations, making informed decisions about product release or rejection.
• Ensure timely completion of deviation reports (gDR/gLIR) and supervise corrective actions.
• Oversee quality investigations to control risks in manufacturing processes.
• Authorize and review stability studies and product quality reviews.
• Prepare and manage inspections by government authorities and customers, ensuring compliance with regulations.
• Handle complaints, coordinate recalls, and investigate root causes of product issues.
• Develop and maintain relationships with external contacts related to quality concerns.
• Provide functional leadership to QA team members by organizing work and promoting structured --working methods.

Skills

Deviation handling

Quality investigations

Aseptic manufacturing

Regulatory knowledge

English documentation

Job description

Company

Our client is a leading organization in the pharmaceutical manufacturing industry, committed to maintaining the highest standards of quality in their production processes. They focus on ensuring product safety, compliance, and continuous improvement through innovative quality management practices.

Job Description

We are seeking a dedicated Senior Quality Assurance Specialist to join the team and support ongoing quality processes. The key focus of this role is to assist in reducing the current backlog of deviation investigations, with an emphasis on deviation handling and writing. The role involves working closely with production and the qualified person (QP) team to ensure compliance and quality standards are maintained, without participation in batch release activities.

Responsibilities

• Manage and resolve deviation reports, including investigating, writing, and documenting deviations.
• Support the QA department in reducing deviation backlog and implementing quality improvements.
• Review and approve master documents and specifications for product release.
• Initiate and assess quality investigations, making informed decisions about product release or rejection.
• Ensure timely completion of deviation reports (gDR/gLIR) and supervise corrective actions.
• Oversee quality investigations to control risks in manufacturing processes.
• Authorize and review stability studies and product quality reviews.
• Prepare and manage inspections by government authorities and customers, ensuring compliance with regulations.
• Handle complaints, coordinate recalls, and investigate root causes of product issues.
• Develop and maintain relationships with external contacts related to quality concerns.
• Provide functional leadership to QA team members by organizing work and promoting structured --working methods.

Requirements

• Minimum 5 years of experience in pharmaceutical quality assurance, with strong exposure to aseptic manufacturing and lyophilization.
• Proven experience in deviation handling and investigation.
• Solid understanding of aseptic processes and visual inspection of lyophilized products.
• Good knowledge of pharmaceutical regulations (EU and US) and analytical methods.
• Excellent command of English, especially for technical documentation.
• Dutch language skills are a plus but not mandatory.
• Experience with automated processes is preferred.
• Strong problem-solving and decision-making skills with a result-oriented approach.

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