Job Title: Executive – QA (Bioanalytical)
Department: Clinical Research
Experience Required: 2–4 Years
Role Overview
The Executive – QA (Bioanalytical) is responsible for ensuring regulatory compliance, maintaining data integrity, and supporting quality systems within the Clinical Research team. The role focuses on analytical data review, audit management, and quality assurance processes.
Key Responsibilities
1. Quality Management Systems (QMS)
Deploy, verify, and report QMS activities through systematic audits
Maintain SOP master lists and controlled procedural documents
Support organization-wide quality initiatives (ISO 9001 & ISO 27001)
2. Analytical Review & Compliance
Conduct project/study-specific analytical reviews
Ensure studies comply with ICH-GCP, regulatory requirements, and protocols
Verify data integrity and adherence to quality standards
3. Audit & Inspection Management
Perform internal system audits and facilitate external audits
Ensure audit readiness and host regulatory inspections
Prepare, communicate, and manage audit reports
Track, follow up, and close audit observations
4. Quality Assurance Support
Assist clinical QA team in quality assurance activities
Conduct QA audits of BA/BE Bioanalytical studies
Identify, escalate, and track quality issues
5. CAPA & Metrics
Perform CAPA effectiveness checks for identified findings
Support development and reporting of quality metrics
Required Skills & Competencies
Strong knowledge of FDA, EMA, ICH, and GLP guidelines
Experience with audit processes and regulatory inspections
Understanding of method development and validation protocols
Attention to detail and strong analytical skills
Good documentation and communication abilities
Preferred Experience
2–4 years of experience in Bioanalytical QA
Exposure to clinical research quality systems and compliance
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