Quality Systems Specialist

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

Company

A leading organization dedicated to advancing healthcare through innovative and quality-driven solutions. Their mission is to support the development and manufacturing of life-saving therapies, focusing on improving patient outcomes worldwide.

Job Description

The Quality Systems Specialist plays a vital role in supporting the deployment and management of the company’s quality systems. This position involves ensuring compliance, facilitating cross-site collaboration, and maintaining high standards in quality assurance activities related to regulated pharmaceutical processes.

Responsibilities

• Oversee the maintenance, training, and continuous improvement of core quality systems such as Change Control, Deviations, CAPA management, and Material Review Board processes.
• Support site and cross-site compliance with regulatory requirements and quality policies.
• Facilitate training sessions and act as a backup chair for the EU Change Control Review Board, Deviations, and Material Review Board.
• Assist in regulatory inspections and audits, ensuring proper documentation and adherence to cGMP standards.
• Manage the review and approval of changes, deviations, CAPA records, and related documentation.
• Track and report metrics to identify opportunities for process improvements and support management reviews.
• Support multidisciplinary teams in startup activities and process improvements.
• Maintain the company’s Quality Management System and ensure timely approval of documents.
• Act as a backup support for the Senior Manager of Quality Systems and contribute to ongoing quality initiatives.
• Perform other related duties as required to uphold quality standards.

Requirements

• At least 5 years of GMP Quality Assurance experience in a pharmaceutical environment (Drug Substance or Drug Product).
• Strong knowledge of GMP regulations, ICHQ10 standards, and relevant pharmaceutical law.
• Hands-on experience with Change Control, CAPA, Deviations, Internal Audits, and Material Review Boards.
• Knowledge of aseptic manufacturing processes.
• Proficiency in MS Word, Excel, PowerPoint, Smartsheet, Power BI, Power Automate, and quality management systems.
• A bachelor’s degree in technical fields such as Chemistry, Microbiology, Engineering, or similar.
• Preferred: Certifications such as ASQ, Black Belt/Green Belt, and experience with ATMPs.

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