​​Summary : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Pa...
Summary : Validate CNC equipment and related processes used to manufacture medical devices. Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment. Aim: Ensure robust,...
Job Description: The client is looking for a calibration technician to come into the sterile fill finish facility and help with the calibration and metrology work within the site. They are currently in the process of bringing all activit...
Job Description: The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in...
Summary: We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in en...
Summary: We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualificati...
Summary We are seeking a highly skilled Data Integrity SME with a strong Quality Assurance background and hands-on experience in analytical equipment documentation within the pharmaceutical industry. The ideal candidate will ensure data in...
Responsibilities: Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close This includes the EDC build and user acceptance testing (UAT), study ...
Responsibilities: Develop, implement, and maintain robust quality management systems aligned with industry standards such as ISO 13485, ISO 9001, and regulatory requirements including FDA regulations. Conduct regular quality audits acros...
Responsibilities: Accurate and timely registration of adverse event and product quality report from initial receipt to data entry within required timeframes. Performing Quality Review of external provider's reconciliation tasks for Clini...