Quality Compliance Sr. Specialist

Overview

Key Responsibilities

• Review & Approve systems needed for analytical method development, validation, verification, and method transfer activities for pharmaceutical products according to ICH, USP, and regulatory guidelines.
• Review & approve system needed for stability studies including protocol preparation, sample scheduling, trend analysis, and reporting for accelerated and long-term studies.
• Review analytical protocols, reports, specifications, test methods and technical documentation to ensure GLP compliance and data integrity.
• Establish Systems to comply with 21 CFR part 11 in QC electronic data
• Oversight method transfers activities between R&D and QC laboratories ensuring reproducibility and analytical robustness.
• Oversight laboratory activities, troubleshooting of chromatographic systems (HPLC/GC), and optimization of analytical performance.
• Oversight laboratory Analytical investigations, OOS, OOT , trending activities
• Provide technical guidance, training, and performance monitoring for analytical team members from GLP compliance point of view.
• Oversight regulatory submissions, change controls, investigations, and audit readiness activities for QC labs.
• Oversight analytical sections of CTD dossiers (Module 3 P Part) including Justification of specifications, impurity profiling characteristics, and supporting analytical documentation in compliance with ICH and regulatory requirements.
• Collaborate with cross-functional departments including RD, QC, QA, Regulatory Affairs, and Production to support product analytical development and commercialization.
• Oversight Raw material analytical methods Verification & validation.
• Oversight laboratories compliance systems to assure updated methods adaptions.