Job highlights
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.
Manipal,India . Life Sciences Graduate .
Desirable Skills and Experience
2 4 years of Bioanalytical QA experience. .

We are currently seeking an Executive - QA (Bioanalytical) to join our Clinical Research team. The role will support the delivery of robust regulatory compliance oversight, data review and integrity, quality systems management, as well as documentation and reporting activities.

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

Desirable 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

Manipal, India

Life Sciences Graduate

Associate

Clinical Research

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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