Executive - QA (Bioanalytical) (Navitas)

Roles and Responsibilities

The role will include the following:

• QMS deployment, verification, and reporting through systematic audits

• Project/study-specific analytical review as a primary responsibility

• Support the clinical quality team in quality assurance activities as required

• Verify and ensure that the studies are conducted as per ICH-GCP, regulatory requirements, and protocol

• Ensure preparedness and hosting of external audits and inspections, and 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 and maintenance of SOP master lists

• Quality Assurance audit of BA/BE Bioanalytical and support clinical QA

• Facilitate and perform system audits

• Audit reports management - preparation, communication, and closure

• Quality issue follow-up, identification, and escalation.

• CAPA effectiveness checks as necessitated for identified findings

• Support and manage organization-wide quality initiatives, specifically ISO 9001 and ISO 27001

Desirale Skills and Experience

• 2 – 4 years of Bioanalytical QA experience

• Deep understanding of FDA, EMA, ICH, and GLP guidelines

• Familiarity with audit processes and regulatory inspections

• Knowledge of method development and validation protocols