Imagine your next project leading critical quality investigations to drive process improvements and ensure regulatory compliance in a dynamic pharmaceutical environment.
...
quality engineer - investigation owner.
- leiden, zuid-holland
- posted 1 day ago
- closes in 4 days
job details
summary
- leiden, zuid-holland
- €5,300 per month
- permanent
- job categoryengineering
job details
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.
Apply now and receive a WhatsApp message within 15 minutes with a few short questions, so we can help you quickly.
Don't have WhatsApp? We'll contact you by phone or email!
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.
Apply now and receive a WhatsApp message within 15 minutes with a few short questions, so we can help you quickly.
Don't have WhatsApp? We'll contact you by phone or email!
experience
Quality Engineer - Investigation Ownerskills
- 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
qualifications
HBO
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