Overview
On Site
Full Time
Skills
Root Cause Analysis
Intellectual Property
IP
Documentation
Backup
GLP
GMP
HPLC
Data Integrity
Regulatory Compliance
Auditing
Corrective And Preventive Action
Titration
Testing
Job Details
Job Summary:
Roles & Responsibilities:
Education & Experience:
- The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards such as 21 CFR Part 11 and Annex 11.
- The role ensures compliance with GLP, GMP, and good documentation practices while supporting validated systems, audit readiness, and laboratory data accuracy.
Roles & Responsibilities:
- Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon).
- Ensure adherence to ALCOA+ principles and regulatory requirements (21 CFR Part 11, Annex 11).
- Review audit trails, monitor user access, and perform periodic data reviews.
- Maintain accurate documentation of chromatograms, integration parameters, and calculations.
- Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II).
- Conduct root cause analysis, hypothesis testing, and propose CAPAs.
- Document OOS investigation narratives and track CAPA effectiveness.
- Perform titration-based content uniformity tests per SOPs and pharmacopeial guidelines (USP, IP, BP).
- Calculate active ingredient content and assess batch uniformity.
- Ensure compliance with GLP, GMP, and good documentation practices.
- Maintain validated systems with secure electronic records, audit trails, and backup protocols.
- Review and approve titration method logs, normality calculations, and endpoint determinations.
Education & Experience:
- Experience working in GLP/GMP-regulated laboratory environments.
- Hands-on experience with HPLC systems (Empower, Chromeleon).
- Experience in data integrity compliance, audit trail review, and periodic data review.
- Experience leading OOS investigations (Phase I & II) and CAPA implementation.
- Experience performing titration-based content uniformity testing per pharmacopeial guidelines.
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