GMP Quality Specialist, Haarlem, Noord-Holland

Company
Our client is an international organisation operating in a highly regulated environment. The company supports the development, supply, and quality oversight of a broad product portfolio and is focused on maintaining high standards of compliance, product quality, and patient safety. They are looking for a quality professional who can support critical quality processes and contribute to continuous improvement.

Job Description
Our client is looking for a GMP Quality Specialist to support quality oversight activities within a regulated pharmaceutical environment. This role focuses on maintaining compliance across products and processes, supporting quality systems, and helping ensure that activities are aligned with internal procedures and applicable regulations.
The GMP Quality Specialist will work closely with key quality stakeholders and play an important role in investigations, documentation, risk assessments, and process improvements.

Responsibilities
- Support quality oversight activities across regulated products and processes
- Create, review, and maintain SOPs and working instructions
- Assist with the execution of GMP and GDP compliance activities
- Support the follow-up and closure of deviations, changes, and CAPAs
- Investigate quality issues and assess their impact on products and processes
- Prepare and contribute to risk assessments, including the use of structured tools such as FMEA
- Document incident-related information clearly and accurately
- Liaise with internal teams and external stakeholders to support investigations and corrective actions
- Contribute to quality system improvements and broader quality-related projects
- Help ensure that quality activities are performed in line with relevant regulations and internal standards

Requirements
- HBO or bachelor’s level education in a relevant field
- Experience working with GMP-related quality processes
- Knowledge of pharmaceutical production and laboratory environments
- Experience with deviations, investigations, and CAPA follow-up
- Familiarity with risk assessments and impact assessments
- Strong documentation and written communication skills
- Structured, independent, and proactive working style
- Strong communication skills in English and Dutch

Other Information
This is a great opportunity for a quality professional who enjoys working in a structured, regulated environment and wants to contribute to high standards of compliance and operational quality.
If you are interested and want to apply, please submit your application via the apply button below and contact me.

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