QC - Sr Executive - Investigation
QC - Sr Executive - Investigation
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Job Description
OOS OOT & Deviation Investigation: Conduct detailed investigations for Out of Specification (OOS) Out of Trend (OOT) and deviations identifying root causes and corrective actions.
CAPA Implementation: Develop and implement Corrective and Preventive Actions (CAPA) to prevent recurrence of analytical failures.
Regulatory Compliance & Documentation: Prepare investigation reports deviation reports and CAPA documents in compliance with USFDA MHRA WHO and EUGMP guidelines.
Data Review & Integrity: Ensure accurate documentation data integrity and compliance with ALCOA principles.
Instrument & Method Review: Evaluate analytical test methods equipment performance and laboratory trends to detect anomalies.
Audit Readiness: Maintain uptodate investigation records and support internal and external regulatory audits.
CrossFunctional Collaboration: Work with QA production and validation teams to implement investigation findings and process improvements.
Required Experience:
Senior IC
Employment Type
Full-Time
