Job Description
Roles and Responsibilities
TDD QC Responsibilities:
LMS Related
- Online & Retrospective review of Articulate interactive E Modules.
- Online & Retrospective check of LMS courses, contents & restriction criteria and audit trails of any changes done as per regulatory requirements
- Ensure the online documentation and completeness of the TDD SOP driven logbook for "reason for change in LMS"
- Responsible for complete updating and maintenance of LMS as a regulatory compliant software
- 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
- 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
- Maintain all documents of TDD as per TDD SOP like agenda, Attendance sheets, TNI etc. and if any file notes and deviation notes
- Review of TDD records for accuracy, completeness and compliance of standard operating procedures.
- To give responses to the QA audits and sponsor audits.
- Involved in CAPA and process improvement of training matrix, risk assessment, documentation, Quality Control, Audits.
- Perform monthly internal audit of TDD activities including LMS activities
Trend Analysis and Areas of improvement
- Perform trend analysis of all TDD Observations received and trend analysis of LMS queries
- 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
Keyskills:
Computer System Validation