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
KEY RESPONSIBILITIES
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 9000 requirements.
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 & EXPERIENCE
Qualification in medicine, science and/or other relevant discipline and appropriate experience.
Previous experience in Quality Assurance auditing – 2 – 5 years.
Detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials.
Ability to review and evaluate clinical data / records.
CRQA is looking for Business Development Partner / Consultant in USA and Europe to promote pharma / clinical quality assurance, GCP audits, GxP audits and other services and acquire new clients in these regions.