The Company
Our client 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 an Senior Quality Assurance Specialist. You will be responsible for overseeing the validation of equipment, automation, and information systems, as well as managing Quality Risk. You will also review and approve validation documentation for equipment and automation, ensuring compliance with corporate, site, and regulatory standards.

Responsibilities
– Collaborates on strategy and provides guidance on design, characterization, and validation with PD, M&E, and IS teams, ensuring GMP quality and compliance.
– Reviews and approves validation documentation and Maintenance & Engineering (M&E) support.
– Reviews and approves changes to M&E procedures, such as changeover processes and preventive and corrective maintenance.
– Manages ABRs device responsibilities to ensure alignment with GMP regulations.
– Represents QA in Quality Risk Management (QRM) activities, including pFMEA, QRAES, and computer system compliance.

Requirements
– MBO or Bachelor’s degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience.
– 2years of 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, computer compliance (Annex 11, Part 11) knowledge with the ability to interpret and apply in mainly routine cases.

Other Information
Are you interested and would like to apply for this position? Feel free to contact me.

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