Roles and Responsibilities
Clinical Quality Assurance Auditor will be responsible for:
Schedule, prepare, conducts and reports assigned audits of the Client’s projects and operational processes in accordance with approved procedures, schedules and formats. Audits include Investigative Sites, Clinical Vendors, Clinical Study Reports and Trial Master Files.
Provide clear, accurate and concise advice on GCP and compliance related questions from Operational teams.
Must have in-depth knowledge of ICH GCP and FDA and EMA regulations and guidance.
Write and issue audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management.
Review responses to audit findings for appropriateness and completeness. Follow up as appropriate to obtain audit response.
Maintain accurate and timely documentation of QA auditing activities.
Serve as Lead Auditor for project audits as required.
Coordinate and conduct internal audits (project, process).
Create, maintain and revise departmental standard operating procedures, forms and templates.
Work with clients/sponsors when required.
Serve as a trainer and mentor to less experienced QA Auditors.
Manage assigned quality issues in accordance with Company requirements.
May be required to host Sponsor audits and assist in Regulatory Inspections.
Qualifications and Background Requirements
Bachelor’s degree (or equivalent) in medicine, pharmacy, life science, or any other relevant field.
3-5 years’ experience in clinical trials /GCP auditing (preferably 3 years in GCP Auditing).
Complete knowledge and application of GCP standards and regulations.
Strong observational, analytical, and communication (written and verbal) skills.
Collaborative skills and ability to work independently.
Experience in conducting GCP, compliance and process audits;
Experience in conducting all audit areas, Investigator Sites, Vendors, Data Management, Biostatistics, Safety Management, Trial Master File etc.
Ability to travel up to 30%-40% of the time.