Quality Change Control Records Owner

The Company
Our client is a leading biotechnology company who innovates, manufactures, and delivers life-changing products to over 10 million patients globally. In the Netherlands, they have over 1,000 professionals from 42 nationalities working together on supply chain processes, manufacturing, marketing, sales, and clinical research.

Role Description
Your role as a Quality Change Control Records Owner to oversee the engineering change control, deviation, and CAPA processes. In this role, you will ensure the completeness, accuracy, and effectiveness of quality records, ensuring compliance with regulatory requirements and Amgen's quality standards. You will also ensure that timelines for completion are met, and quality records are well maintained.
Responsibilities

• Change Controls: Manage the change control process, ensuring all changes are properly documented, reviewed, and approved in line with regulatory standards and Amgen's quality guidelines.
• Deviations: Lead the documentation of deviations, facilitate Root Cause Analysis (RCA) meetings, and ensure implementation of corrective/preventive actions.
• CAPAs: Oversee the CAPA process to ensure corrective and preventive actions are tracked, documented, and completed to address root causes and prevent recurrence.
• Collaboration: Collaborate with cross-functional teams to maintain accuracy and completeness of all quality records.

Requirements

• Bachelor's degree in a related field (e.g., Engineering, Life Sciences).
• Minimum 2 years of experience managing Change Controls, Deviations, and CAPAs in a GMP-regulated environment.
• Applied knowledge of Advanced Quality tools like Failure Modes Effect Analysis (FMEA) and Root Cause Analysis (RCA).
• Strong understanding of regulatory requirements such as Eudralex Annex 15, FDA CFR 21 Part 210 and 211, and industry best practices.
• Fluent in English with excellent technical writing, communication, and organizational skills.
• Strong analytical and problem-solving skills.

Other Information

• If you think this role is for you and you want to explore more of the possibilities, please contact Leri Salve Lapore and apply via the button below.

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