The Company
Our client is a global healthcare and life sciences organization with a strong presence in the Netherlands, focused on developing innovative therapies and vaccines to address major global health challenges. The company operates in a highly regulated, technology-driven environment and promotes a collaborative culture centered on innovation, quality, and continuous improvement.
About the Role:
This role is focused on leading quality investigations within a pharmaceutical manufacturing environment, ensuring product quality, compliance, and operational excellence. The Senior Quality Engineer manages non-conformance investigations, CAPA activities, and change controls while identifying root causes and implementing corrective actions. The position collaborates closely with cross-functional teams to maintain regulatory compliance, improve processes, and ensure timely closure of quality records.
Responsibilities:
- Lead and manage quality investigations, including non-conformances, root cause analysis, and resolution of quality issues.
- Oversee CAPA and Change Control processes to ensure timely implementation of corrective and preventive actions.
- Review and maintain quality documentation, ensuring compliance with GMP, regulatory requirements, and internal standards.
- Conduct risk assessments, implement mitigation plans, and drive continuous quality improvement initiatives.
- Coordinate cross-functional teams, monitor investigation progress, and communicate risks, findings, and outcomes to stakeholders and management.
Requirements:
- Relevant Bachelor's (HBO) degree with 7–10 years of experience in Quality Engineering, investigations, or pharmaceutical manufacturing.
- Strong experience managing non-conformance investigations, CAPA activities, and Change Control processes within a GMP-regulated environment.
- Proven expertise in root cause analysis, risk assessment, problem-solving, and continuous improvement methodologies.
- Excellent stakeholder management, communication, and cross-functional team coordination skills with the ability to manage multiple priorities.
- Proficiency in MS Office, data analysis, and quality systems, combined with strong organizational skills and English language proficiency (B2+).
Other Information:
Looking for a new opportunity? Well, it's right here! If you're interested, please click the below button to apply for the job.
58148
Share This Job
Santosh Yadav
Similar projects
Maintenance Work Planner
Sector: Pharmaceuticals
⚙️Ref: 58188Temporary
Senior EDI & Application Specialist (Order to Cash)
Sector: Food
⚙️Ref: 58187Temporary
Application Specialist
Sector: Food
⚙️Ref: 58186Temporary
Customer Service Representative
Sector: Chemicals
⚙️Ref: 58183Temporary
Product Development Specialist (Dairy)
Sector: Food
⚙️Ref: 58176Temporary
Production Line Operator
Sector: Pharmaceuticals
⚙️Ref: 58182Temporary
Staff Scientist
Sector: Pharmaceuticals
⚙️Ref: 58181Temporary
Staff Scientist
Sector: Pharmaceuticals
⚙️Ref: 58180Temporary
Staff Scientist – Microbiological Quality & Sterility Assurance (MQSA)
Sector: Pharmaceuticals
⚙️Ref: 58179Temporary
R&D Product Development Specialist (Cheese & Dairy)
Sector: Food
⚙️Ref: 58178Temporary