Executive-QA (Bioanalytical)

Role & responsibilities

• QMS deployment, verification & reporting through systematic audits.
• Project/study specific analytical review as a primary responsibility.
• Support clinical quality team in quality assurance activities as required.
• Verify and ensure that the studies are conducted as per ICH-GCP, regulatory requirements, protocol.
• Ensure preparedness and hosting of external audits and inspections & timely follow up and closure of audit observations.
• Support organization-wide Quality Initiatives.
• Support in providing required metrics for quality measurement.
• Controlled procedural documents custody, maintenance of SOP master lists.
• Quality Assurance audit of BA/BE Bioanalytical & support clinical QA.
• Facilitate and perform system audit.
• Audit reports management - preparation, communication, closure.
• Quality issue follow-up, identification and escalation.
• CAPA effectiveness check as necessitated for identified findings.
• Support and manage organization-wide quality initiatives viz: ISO 9001, ISO 27001.

Preferred candidate profile

• Experience with bio analytical method development, validation and study conduct.
• Knowledge of the BA/BE related activities
• Knowledge and understanding of ICH- GCP, GLP and Regulatory Resources (USFDA, EMEA, HEALTH CANADA, TGA guidelines)
• Knowledge and understanding of Standard Operating Procedures