Senior Executive - Clinical QA (Corporate Quality Assurance)

Role & responsibilities:

• Experience of conducting Investigator site audits or monitoring of Clinical Trial/Patient PK studies or BA/BE studies.
• Experience of conducting Investigator/CRO/Vendor qualification audit.
• Well versed with various regulatory requirements (eg.USFDA/EMA/Canada/TGA/ANVISA etc.) for preparation and review of study protocol and site SOPs.
• Hands-on experience of handling Informed consent documentation/process, IMP shipment records, source records, essential documents, and study-related data.
• Should have thorough understanding of regulatory requirements for ensuring subject safety, data integrity, protocol compliance, and study documentation.
• Sound knowledge of Quality Management System such as SOPs drafting, deviation/ CAPA / change control process, Training Records, Instrument calibration, archive etc.
• Experience of writing monitoring/audit reports and ability to understand corrective and preventive actions taken to any findings.
• Having trained on ICH GCP and GLP requirements.