The Company
Our client is a global biotech company focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.

Role Description
As a Quality Management System Specialist, you will be responsible for managing engineering change control, deviation, and CAPA records, ensuring their completeness, accuracy, and effectiveness. You will also ensure that all quality records are maintained in compliance with regulatory requirements and Amgen’s quality standards, while meeting established timelines for completion.

Responsibilities
– Manage the change control process to ensure all changes are properly documented, reviewed, and approved according to regulations and Amgen standards.
– Record deviations, lead Root Cause Analysis meetings, and ensure root causes are identified and addressed.
– Document, track, and complete corrective and preventive actions to resolve issues and prevent them from recurring.
– Collaborate with cross-functional teams to ensure quality records are accurate and complete.

Requirement
– Bachelor's degree in a relevant field (e.g., Engineering or Life Sciences).
– At least 2 years of experience managing Change Controls, Deviations, or CAPAs in a GMP-regulated environment.
– Proven knowledge of advanced quality tools like Failure Modes Effect Analysis (FMEA) and Root Cause Analysis (RCA).
– Proficient in English with excellent technical writing skills.
– Prior experience interacting with regulatory agencies is a plus.

Other information
Are you interested? Click on Apply Button

53592