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Functional Quality Specialist II
2 weeks ago
Description
: Take ownership of assigned aspects of quality reviews on projects Compile metrics and identify quality trends Assist in addressing periodic client quality reviews and other ad-hoc client quality findings Prepare initial drafts of Corrective and preventive actions Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea's clients e.g. Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC's, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelinesFortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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Manager II, Quality
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Manager II, Quality
2 weeks ago
Pune, Maharashtra, India Concentrix Full timeDescription The Manager II, Quality is responsible for managing Transaction Monitoring for clients with multiple programs or lines of businesses which can be across multiple sites/geos. This position supervises all Quality staff members who support their assigned portfolio. He/she is responsible for the accuracy of evaluations, analysis and overall...
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Specialist Quality
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Pune, Maharashtra, India METRO Global Solution Center IN Full timeMetro Global Solution Center (MGSC) is METRO's internal solution partner, a major international wholesaler with presence in 31 countries and 661 stores, supported by a team of 93,000 people. Metro also operates in 10 additional countries through its Food Service Distribution (FSD) business, making it active in a total of 34 countries. MGSC is located in Pune...
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Quality Assurance Specialist
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Pune, Maharashtra, India METRO Global Solution Center IN Full timeMetro Global Solution Center (MGSC) is internal solution partner for METRO, a €29.8 Billion international wholesaler with operations in 31 countries through 661 stores & a team of 93,000 people globally. Metro operates in a further 10 countries with its Food Service Distribution (FSD) business and it is thus active in a total of 34 countries.MGSC, location...
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Quality Assurance Specialist
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Specialist, Quality FL
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Pune, Maharashtra, India Etraveli AB Full timeAbout us: Etraveli Group is the globally leading company for tech solutions and fulfilment capabilities for online sales of flights. We are here to solve complexity, by connecting millions of flights and travellers across the globe, from search and selection to trip and beyond. We hold consumer online travel agency brands like Mytrip, GoToGate & Flight...
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Functional Quality Specialist I
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Pune, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Quality Assurance Specialist
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Pune, Maharashtra, India METRO Global Solution Center IN Full timeMetro Global Solution Center (MGSC) is the internal solution partner for METRO, an international wholesaler with operations in 31 countries through 661 stores & a team of 93,000 people globally. Metro also operates in 10 countries with its Food Service Distribution (FSD) business, totaling 34 countries.MGSC has locations in Pune (India), Düsseldorf...
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Pune, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Pune, Maharashtra, India Artifex HR Private Limited Full timeJoin Our Team at Artifex HR as a Quality Assurance Specialist for a Healthcare Client in PuneRoles and Responsibilities:Knowledge on Risk adjustment models - Medicare, Commercial and Medical aid.Proficient in coding standards and guidelines including ICD CM guidelines, AHA coding clinic updates and client-specific requirements.Conduct QA audits for multiple...
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