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QTC Analyst

1.00 to 2.00 Years   Hyderabad   14 Feb, 2020
Endpoint Clinical , Inc
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Position Description :

Title: QTC (Quality, Trust, and Compliance) Analyst

Position Overview: The QTC Analyst is primarily responsible for ensuring compliance for product release launch activities and post - launch compliance and ensuring compliance as set forth by regulatory agencies and endpoint Quality Management System (QMS).

Responsibilities:
  • Provide QTC review and approval of in - process tasks related to product and/or service provision
  • Generate, perform review, and maintain records of Validation Deliverables documentation and ensure compliance to procedures and
  • Provide support to operations staff to develop, write, and revise controlled Validation Deliverables.
  • Act as primary QTC representative and resource to Operations staff with regards to product release
  • Provide ad hoc training to Operations staff on compliance procedures associated with product release
  • Assist with tracking and trending all KPIs (quality metrics) and conducting periodic Product Quality review with key stake holders
  • Maintain validation documentation in QMS according with company procedures
  • Coordinate record archival and retrieving at study closedown of live IRT
  • Assist in preparation, review, and maintenance of reports for identified product events
  • Participate in Root Cause Analysis meetings with the Operational staff and provide input on the identification and documentation of Corrective Actions/ Preventive Actions for events of discrepancy or failure of released product
  • Assist CAPA team in completion of outstanding CAPA items with the appropriate
  • Support the Governance unit in preparation for External Audits related to product
  • Perform QMS documentation Quality Control (QC) reviews on controlled documents such as SOPs, Work Instructions and Policies as well as provide feedback to key stakeholders as
Accountabilities :
  • Demonstrate efficient and accurate completion of all
Qualifications :

Education

Bachelor s degree in related scientific or technical discipline

Experience:

1 - 2 years of relevant working experience within a regulated environment or

Familiarity with FDA regulations (21 CFR Part 11, EU Annex 11) regulations and current industry best practices.

Knowledge of U.S. and international regulatory standards and guidelines

Experience with a QMS and LMS a plus, but not required

Skills Required

Strong communication (written and verbal), organizational, and interpersonal skills.

Project management skills and high level of attention to detail.

,

Keyskills :
rootcauseanalysis qualitymanagementsystem rootcause supplychain socialmedia externalaudit qualitycontrol productquality technicalsupport managementskills workinstructions managementsystem projectmanagement qualitymanagement workingexperience

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