Required Sr. CT QA-Auditor

Company Name: Exemed Pharmaceuticals ( Formulation Business)

Designation: Sr. CT QA-Auditor

Experience Range: 4-5 years

Required Qualification: B. Pharm or M. Pharm (Pharmacology) or Msc in Clinical Research

Name of Replacer, Please Specify: New Position

Required Skill Set:

1. Must have experience of CT Phase 3 & Phase 4 Audits

2. Ready for travelling

3. Familiar with ICH-GCP guidelines

4. Proficient with MS excel, MS word and Power point

5. Experience with oncology trials is an additional advantage

Job Description (Compulsory):

1. Prepare audit agenda, checklist and reports

2. Conduct and oversee audits of investigators site, vendors facilities and systems

3. Review of Site Master File

4. Review trial related documents such Study Protocols, CRFs, ICDs and Patient diary, Investigators Brochures and Patient diaries

5. Participate in regulatory inspections

6. Prepare various reports, intimation letters and arrange meetings as required

7. Communicate identified risks to reporting manager.