Quality Management System

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 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 Amgen quality standards and timelines for completion are met.

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.

Requirements
– Bachelor's degree in a related field (e.g., Engineering or Life Sciences).
– Minimum 2 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).
– Fluent in English with strong technical writing skills
– Excellent communication and organizational skills.
– Experience in interacting with regulatory agencies is preferred

Other information
Are you interested? Feel free to contact me!
 

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