QA Executive Clinical Trials

Postgraduate in Life Science or MSc in Clinical Research with 1-2 years of experience in the same domain

Job Description:

• Plan, coordinate, and execute study audits to assess the compliance with clinical processes, protocols, and procedures.
• Provide support in external/client audits and regulatory inspections hosted by Auriga.
• Support the operations team for adequate root cause identification, conducting gap analysis and implementation of corrective action plan.
• Supporting the CAPA management in audit and Inspection related CAPAs.
• Support the document life cycle management, deviation handling process and change control process as back-up.
• Prepare reports to communicate outcomes of quality activities.
• Draft and or/review of company standard operating procedures (SOPs) and such other documentation.
• Create Induction training documents for the new joiners in the clinical team in consultation with Head- Quality Assurance and /or Head CT/PV.
• Maintaining training files of all the clinical team of Auriga.
• Provide Assistance in audit and inspection readiness activities at Auriga.