Associate Quality Engineer

The Company
Our clients is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.

 Role Description
As a Qualification & Validation Engineer, you will be responsible for perform QA oversight for validation of equipment, automation and information systems and for Quality Risk Management, as well perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.

Responsibilities
– Process, equipment and IS validation, agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
– Reviews and approves validation documentation, reviews and approves changes to equipment.
– Reviews and approves changes to M&E procedures (change over process, preventive and corrective maintenance), device and combination product.
– Quality Risk Management (QRM), represents QA in QRM activities (pFMEA, QRAES, Computer system compliance), and change control.
 Requirements
– MBO or Bachelor’s degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience.
– Relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation.
– Good Manufacturing Practice (GMP), equipment and automation/IS validation, knowledge with the ability to interpret and apply in mainly routine cases.
– Manufacturing and/or Quality analytical processes and operations.

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