Overview
QMS Specialist Jobs in India at Imaging Endpoints
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.
Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts;
London, UK;
Leiden, Netherlands;
Basel, Switzerland;
Hyderabad, India and Shanghai, China. We are an affiliate of Honor Health, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/Rad Partners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The QMS Specialist is primarily responsible for assisting QMS Leadership in executing day-to-day tasks associated with managing, maintaining, and continually improving the Imaging Endpoints Quality Management System. The QMS Specialist is a compliance and solutions-oriented individual who plays a key role in achieving business and stakeholder needs with respect to quality assurance principles and practices.
QMS SPECIALIST
RESPONSIBILITIES
– Provide quality system management assistance within the regulations of investigational products and quality standards, specifically: 21 CFR Part 312, 21 CFR Part 211, and ISO 13485.
– Provide direct QA support related to Imaging Endpoints training programs, nonconformance management (deviation program and CAPA program), QMS auditing programs (internal audits, external audits), and vendor management programs.
– Manage and maintain the IE audit programs, including scheduling, coordination, and performance of both internal and vendor audits.
– Manage and maintain the IE vendor qualification and management program.
– Conduct routine Vendor qualification file audits to trigger required updates and performance of specified vendor maintenance activities (e.g., file updates, vendor audits, etc.).
– QA responsibilities include, but are not limited to, GxP documentation creation, editing, and/or review for procedures related to the QMS.
– Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional, and organizational relationships to drive compliance to specified program objectives.
– Interface with Compliance and Regulatory Affairs Management to implement quality system strategies and plans which facilitate continuous QMS improvement.
– Interface with other areas of the organization to provide sound decision-making in areas that impact the QMS and/or IE compliance to regulations and guidance documents.
– Assist the QMS Management in the management, maintenance, and reporting of IE CAPA and Deviation systems, including discrepancy investigation and reporting, as well as tracking and trending activities.
– Assist Compliance and Regulatory Affairs Management during Internal Audits, Sponsor Audits, or Regulatory Inspections, including the effective preparation of related documentation, training of staff, providing accurate information and tracking of audit responses.
– Assist the QMS Director/Management in establishing and reporting applicable quality metrics.
– Ensure proper control, retention, and archival of QMS documentation.
– Assist in establishing, implementing, and maintaining QA procedures and controls to develop a compliant IE QMS.
– Perform other duties as assigned by Compliance and Regulatory Affairs Management. Act in a supporting role to other QMS positions.
EDUCATION AND EXPERIENCE
– Bachelor’s degree in pharmaceutical sciences or other related scientific disciplines.
– Minimum three (3) years of experience in a regulated industry with at least two (2) years of experience in pharmaceuticals and/or medical device.
– QMS experience.
– QMS…
Title: QMS Specialist
Company: Imaging Endpoints
Location: India
Category:
