Quality Management Specialist
3 weken geleden
Job Title: Quality Management Records Owner (Change Controls, Deviations, CAPAs)
In this role, you will be the owner of engineering change control / deviation/ CAPA records, assuring the completeness, accuracy and effectiveness of these records. You will ensure that all quality records are maintained in compliance with regulations and company quality standards and timelines for completion are met.
Key Responsibilities:
- Change Controls: Manage the change control process, ensuring that all changes are documented, reviewed, and approved in accordance with regulations and Amgen standards.
- Deviations: Document deviations, facilitate and lead Root Cause analysis meetings to ensure that root causes are identified, and corrective / preventive actions are implemented.
- CAPAs: Ensure that corrective and preventive actions to address identified issues and prevent recurrence are identified, documented and tracked to completion.
- Collaboration: Work closely with various cross functional teams, to ensure the accuracy and completeness of quality records.
Qualifications:
- Bachelor's degree in a related field (e.g., Engineering, Life Sciences).
- Excellent technical writing skills
- Minimum 3 years of experience in handling Change controls / deviations / CAPAs, in a GMP regulated environment
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), Root Cause Analysis (RCA).
- Strong knowledge of regulatory requirements such as Eudralex Annex 15, FDA CFR 21 Part 210 and 211 and industry best practices related to quality records management.
- Experience in interacting with regulatory agencies is preferred
Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502 for more info.
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