Junior Auditor – CRQA at Veeda CR, Ahmedabad

Veeda CR is hiring a Junior Auditor (CRQA) in Ahmedabad. The role requires 1 – 5 years of experience and a B.Pharma, M.Sc (Science) or M.Pharma qualification in any specialization.

Job Details

Job Details Information
Company Veeda CR
Job Title Junior Auditor – CRQA
Location Ahmedabad
Work Experience 1–5 years
Salary ₹3–6 LPA
Employment Type Full Time, Permanent
Number of Openings 2
Role Category Quality Assurance – Other
Department Quality Assurance
Industry Type Pharmaceutical & Life Sciences

Job Description

  • Experience in clinical study audits including phase 1 and BA/BE studies, knowledge of ICH-GCP and Indian GCP, expertise in CAPA, SOP and QMS review
  • Plan and execute clinical study audits, review essential documents and protocols, conduct TMF and IMP audits, assist in regulatory inspections and software validation

Key Responsibilities

Planning and Execution

  • To prepare audit plan, audit report compilation, compliance verification, corrective and preventative actions (CAPA) closure of
  • Study-based audits for clinical studies (including phase 1 and patient-based, BA/BE studies) as per audit plan in compliance with ICH-GCP, Indian GCP, internal procedures, protocol and applicable regulatory requirements.
  • Clinical studies audit and releasing audit certificate.
  • In-process audits of IMP distribution, dispensing & retention

TMF audits

  • To conduct audit as per SOP & QA audit plan
  • To perform essential documents, review for clinical studies (including phase 1 and BA/BE studies) in compliance with ICH-GCP, Indian GCP, internal procedures, protocol and applicable regulatory requirements.
  • Protocol and Case Report Form Review
  • Informed Consent Form review
  • Study specific plan review (e.g. Project Management Plan, Data Management Plan, SAP (statistical analysis plan, etc.)
  • Clinical Study Report (which includes biostatistics reports) Review

Quality Management System

  • SOP review of Quality Assurance SOPs and review of applicable system SOPs.
  • To review Change Control and Deviation
  • To review of incident/event/investigations
  • To assist in software validation activities as a QA role.
  • To ensure the controlling and distribution and QA data archiving activities.

Other QAD Activities

  • Interpretation of guidelines and regulations
  • To assist Sr. Auditor in sponsor/client audits and regulatory inspections as and when required.
  • Any other task assigned by reporting authority.
  • To update tracker as per work delegation by Sr. Auditor.

Eligibility Criteria

  • UG: B.Pharma in Any Specialization
  • PG: MS/M.Sc (Science) in Any Specialization, M.Pharma in Any Specialization
  • Work Experience: 1 – 5 years

Required Skills

  • Quality Assurance
  • GCP
  • ICH-GCP
  • Capa
  • Ba/Be Studies
  • Clinical Research
  • QMS
  • Change Control
  • Deviation
  • SOP

CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE