CRQA – www.crqa.in
is an upcoming clinical regulatory
quality assurance firm, established by the senior professionals from the clinical
research and pharmaceutical industry.
CRQA is looking for QA and Auditing professionals on part time or assignment basis
at various locations in India with auditing experience in the following areas:
- GCP Audits
- Clinical Operations
- CRO Audits
- Central Lab and Bio analytical Lab Audits
- Clinical Trial Supply Audits
- IRB Audits
- System Audits
- Data Management Audits
- Essential Document Audits
- Pharmacovigilance Audits
- GLP / GMP Audits
- SOP Development
- Regulatory Inspections Preparations
- Perform QA audits of clinical trial data and records in order to assure compliance
with client SOPs, study protocols, GCP guidelines, relevant regulations and ISO
- Plan and conduct regular and random QA audits.
- Perform quality system audits and contract audits for Sponsors.
- Ensure that audit results are formally recorded and reported and that corrective/preventive
actions are documented.
- As an auditor, perform the duties assigned in an efficient and effective manner.
This includes liaison with the sponsors on all QA issues, including audit planning
and review of audit results.
- QA Training.
- Qualification in medicine, science and/or other relevant discipline and appropriate
- Previous experience in Quality Assurance auditing – 2 – 5 years.
- Detailed knowledge of GCP guidelines and relevant regulations for the conduct of
- Ability to review and evaluate clinical data / records.
- Excellent communication and interpersonal skills.