Required Skills

Audit report Life sciences Equipment calibration ICH

Work Authorization

  • Citizen

Preferred Employment

  • Full Time

Employment Type

  • Direct Hire

education qualification

  • UG :- - Not Required

  • PG :- - Not Required

Other Information

  • No of position :- ( 1 )

  • Post :- 4th Nov 2022


  • Plan, conduct and mange Internal audits (Study Inprocess & Retrospective, System Audit) and Vendor audits as per the plan in compliance with ICH-GCP, Protocol, SOPs and applicable GxP standards/ regulations.
  • Preparation of audit reports for the audits conducted and release the audit report to auditee.
  • Preparation/Review of SOPs, review of study protocols and clinical study reports
  • Assess suitability of responses to audit findings and negotiate suitable actions needed to satisfactorily resolve audit findings.
  • Review of deviations and CAPA plans and follow-up CAPA plans and ensure for its implementation and closer.
  • Assist in preparation of the facility for client/sponsor audits and regulatory inspection
  • Perform the reconciliation of Project and Non-project related documents and send for archival
  • Review the equipment calibration/validation records

Skills/ Qualifications:

  • Strong written and verbal communication skills
  • Strong analytical and problem solving skills
  • Good computer skills
  • Self-motivated and able to prioritize the work.

Education & Experience:

  • Education in Life Sciences (B.Sc/M.Sc/B.Pharm/M.Pharm)
  • 2- 5 years experience in GCP quality assurance audits and knowledge on ICH-GCP and US and EU regulations and applicable GxP standards/Regulations.

Company Information