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Vacancy For the Post of CSV QC - Ahmedabad @ Veeda Clinical

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 Vacancy For the Post of CSV QC - Ahmedabad

Job Description

Roles and Responsibilities

TDD QC Responsibilities:

LMS Related

  1. Online & Retrospective review of Articulate interactive E Modules.
  2. Online & Retrospective check of LMS courses, contents & restriction criteria and audit trails of any changes done as per regulatory requirements
  3. Ensure the online documentation and completeness of the TDD SOP driven logbook for "reason for change in LMS"
  4. Responsible for complete updating and maintenance of LMS as a regulatory compliant software
  5. Ensure that all the queries observed in the software is addressed by TDD and/or ICT with proper documentation like event reports/incidence reports etc. and maintain a track of it
  6. Responsible for LMS QC CHECK like disable cohorts e.g. all left employees, handling of IJP in LMS etc.

Documentation GDP compliance, SOP compliance & Audits related

  1. Maintain all documents of TDD as per TDD SOP like agenda, Attendance sheets, TNI etc. and if any file notes and deviation notes
  2. Review of TDD records for accuracy, completeness and compliance of standard operating procedures.
  3. To give responses to the QA audits and sponsor audits.
  4. Involved in CAPA and process improvement of training matrix, risk assessment, documentation, Quality Control, Audits.
  5. Perform monthly internal audit of TDD activities including LMS activities

Trend Analysis and Areas of improvement

  1. Perform trend analysis of all TDD Observations received and trend analysis of LMS queries
  2. Focus on the area of improvements for TDD with discussion with Head, TDD

Job Classification

Industry: Medical, Healthcare, Hospitals
Functional Area: Other,
Role Category: Not mentioned
Role: Not mentioned
Employement Type: Full time

Education

Under Graduation: B.Pharma in Any Specialization, B.Sc in Any Specialization
Post Graduation: M.Pharma in Any Specialization, MS/M.Sc(Science) in Any Specialization
Doctorate: Ph.D in Medicine, Pediatrics, Advertising/Mass Communication, ENT, Neonatal, Dermatology, Psychiatry, Obstetrics, Radiology, Rheumatology, Pathology, Doctorate Not Required

Contact Details:

Company: Veeda Clinical Research Pvt Ltd
Address: Insignia, Besides Auda Garden, Opp. Zenobia Residency, Sindhu Bhavan Road, Off. S. G. Highway, Bodakdev, Ahmedabad- 380059, Gujarat, India.
Location(s): Ahmedabad

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Keyskills:   Computer System Validation

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₹ 2,00,000 - 4,00,000 P.A

Veeda Clinical

Veeda CR is an independent Clinical Research Organization established in the year 2004 at Ahmedabad, Gujarat, India. Veeda CR was established with a vision of creating a CRO pharma with an in-depth scientific know-how, technical edge and better foresight for clinical trials, an objective of beco...