Quality Engineer - Investigation Owner in Leiden

Imagine your next project leading critical quality investigations to drive process improvements and ensure regulatory compliance in a dynamic pharmaceutical environment.

The Quality Engineer - Investigation Owner is responsible for leading and managing quality investigations related to manufacturing processes, products, and systems. This role involves identifying root causes of quality issues, coordinating corrective and preventive actions, and ensuring compliance with internal standards and regulatory requirements. The Quality Engineer works closely with cross-functional teams to document findings, drive process improvements, and communicate results to stakeholders. Strong analytical skills, attention to detail, and effective problem-solving abilities are essential for success in this position.

Experienced individual contributor that executes tasks that are both routine and not routine. Assembles and leads the team required for quality records. Escalates issues and risks as required. Demonstrates effective communication skills. Maintains high standards of professionalism, efficiency, personal communication, discretion, and independent judgment.

Main responsibilities.

Applies expertise knowledge of Quality requirements to support the handling of quality records

Perform non-conformance investigations, including CAPA records and lead change controls (CC) for the operations unit from initiation through completion.

Reviews documentation associated with processes and activities for the Operations unit products.

Maintains procedures and applicable documentation and makes updates based on new or revised regulatory requirements, internal investigations, and audits.

Ensure compliant documentation and timely completion of quality records.

Initiates and implements risk mitigations and continuous quality improvement projects, under limited guidance.

Supports with formal escalation processes to ensure visibility of risks associated with safety, product quality and regulatory compliance.

Perform regular GEMBA walks to observe and document adherence to GMP standards on the production floor, identify areas for improvement, and collaborate with team members to implement corrective actions.

Functie-eisen

A relevant HBO degree (Life Sciences, BioTech etc) with 3 - 5 years relevant experience, in an investigation lead, Quality engineer, or similar role within pharmaceutical industry.

English B2 language level is required.

Are available for an assignment of 1 year, working on-site 2 days per week

GMP Knowledge

Competenties

Strong analytical mindset with the ability to navigate complex data and identify root causes

Decisive and organized self-starter who thrives independently and in cross-functional teams

Stress-resistant and composed when managing tight deadlines and shifting priorities

Clear, persuasive communicator capable of building strong alignment with stakeholders

High commitment to accuracy, personal accountability, and quality standards

The levels of computer proficiency are intermediate level for MS office, routine level for data analysis, and specialist level for business applications.

Arbeidsvoorwaarden

A contract for a year of 40 hours per week (with possibility tot extend)

A monthly project allowance 4% of your salary

25 holiday days.

8% Holiday Pay

A travel allowance 0.21per KM or NS BusinessCard

A good pension scheme (flexsecurity)

Extra allowances for a home workplace budget E750.-

A training budget, coaching, an onboarding program, and unlimited access to the Randstad Academy with over 3,000 courses and trainings

Networking events and knowledge sessions,

Bedrijfsinformatie This international pharmaceutical and innovative healthcare company focuses on developing and delivering high-quality medical solutions and medicines. Within a dynamic, fast-changing campus environment, diverse disciplines and quality levels collaborate closely to translate scientific innovations into impactful healthcare. The organization upholds the highest standards for safety, health, environment, and quality (EHS and GMP). Driven by a strong quality mindset and continuous focus on process improvement, the company ensures a reliable and safe infrastructure where both internal experts and external facility partners collaborate to deliver sustainable, efficient campus facilities.

About the client:

You will work within the Analytical Development department of a leading pharmaceutical organization. The Testing Operations team (part of Strategic Operations) fosters a collaborative, quality-focused culture centered on professional standards and continuous improvement.

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