Change Control Owner

The Company
Our client is a global leader in the healthcare industry, providing high-quality products and services in pharmaceuticals, medical devices, and consumer health. They are committed to innovation, excellence, and improving lives.
 
Role Overview
We are seeking a Change Control Owner (Change Controls, Deviations, CAPAs) to join a leading biotech manufacturing site. In this role, you will be responsible for managing quality records related to engineering change controls, deviations, and corrective/preventive actions (CAPAs). You will ensure compliance with regulatory requirements and internal quality standards, maintaining the completeness, accuracy, and effectiveness of these records.
 
Key Responsibilities
-Change Controls: Oversee the change control process, ensuring proper documentation, review, and approval in compliance with regulatory and company standards.
-Deviations: Document and manage deviations, lead Root Cause Analysis (RCA) meetings, and drive the identification and implementation of corrective/preventive actions.
-CAPAs: Ensure corrective and preventive actions are properly documented, tracked, and completed to address identified issues and prevent recurrence.
-Collaboration: Work cross-functionally with engineering, quality, and operations teams to ensure quality records are complete and aligned with compliance requirements.

Requirements
-Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences).
-Minimum of 3 years of experience managing change controls, deviations, and CAPAs in a GMP-regulated environment.
-Strong knowledge of regulatory requirements such as Eudralex Annex 15, FDA CFR 21 Part 210 and 211.
-Applied experience with advanced quality tools, including Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA).
-Excellent technical writing, analytical, and problem-solving skills.
-Ability to work independently and collaboratively within a team.
-Experience interacting with regulatory agencies is preferred.
-Fluency in English.
 
Additional Information
This is an exciting opportunity to play a key role in maintaining and improving quality processes within a world-class biotech manufacturing environment. If you have a passion for quality and compliance, apply today!
 

54581