Sina Medical Glass

Quality Engineer/QC Supervisor

Posted: 8 hours ago

Job Description

Sina Medical Glass, Ltd. is looking for an experienced Quality Engineer/QC Supervisor to assist in the establishment and implementation of their QMS to ISO 9001 and ISO 15378 standards and function as a Deputy Quality Manager. Sina is a UK start-up with an international team and a compelling mission to ensure the production and ready supply of top-quality vials and cartridges for injectable medications within the UK and abroad. Requirements: Completed studies (Bachelor’s degree required, or equivalent experience) in physics, chemistry, pharmaceutical engineering, primary packaging manufacturing, material science, engineering, or science.Previous experience in quality engineering and/or QC management and validation. Knowledge of regulatory requirements and quality standards in the pharmaceutical industry – especially ISO 9001, ISO 15378, or similar medical devices.Experience in data trending, analysis, and optimization of processes.Experience in document control and document generation (SOPs, WI, Forms, etc). Desire to grow and learn with the company.  Desired (not required): Master’s of Science is preferred, or equivalent experience. Project management, QMS establishment, people management or experience with a start-up pharma, medical devices, and/or manufacturing. Experience in data trending, analysis, and optimization of processes specifically in a production or highly controlled environment.Experience/familiarity with parenteral drug manufacturing requirements or development.Familiarity with USP chapters, <660>, <790>, and relevant ISO and ASTM standards.  Your Tasks: Definition and further development of the quality management system and processes for primary packaging systems based on guidelines, standards and internal know-how.Document writing and supporting project management, and production sites in documentation and implementation quality assurance processes.Initiation and/or support of projects for production process stability and validation of equipment.Support in the creation, maintenance and implementation of quality reports, audits and data analysesInitiation and/or support of projects for production process stability and validation of equipment.Support in internal audits as well as co-design of training and education on quality standards and SOPsQA deputy manager, QC supervision, support, and testing as needed.This role reports to the Head of Quality. Please feel free to contact Hannah with any questions at hblystra@sinamedicalglass.com Submit CV/Resume and Cover Letter to: Umit Yilmaz at uyilmaz@sinamedicalglass.com

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