Quality Compliance Sr. Specialist
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Key skills for this role
About the Role
Acino Pharma seeks a Quality Compliance Sr. Specialist to oversee analytical method development, validation, transfer, and stability studies in compliance with ICH, USP, GLP, and regulatory requirements.
Key Skills for This Role
Responsibilities
- Review and approve systems for analytical method development, validation, verification, and method transfer activities
- Review and approve systems for stability studies including protocol preparation, sample scheduling, trend analysis, and reporting
- Review analytical protocols, reports, specifications, test methods, and technical documentation for GLP compliance and data integrity
- Establish systems to comply with 21 CFR Part 11 in QC electronic data
- Oversee method transfers between R&D and QC laboratories ensuring reproducibility and analytical robustness
- Oversee laboratory activities, troubleshooting of chromatographic systems, and optimization of analytical performance
- Oversee laboratory analytical investigations, OOS, OOT, and trending activities
- Provide technical guidance, training, and performance monitoring for analytical team members
- Oversee regulatory submissions, change controls, investigations, and audit readiness for QC labs
- Oversee analytical sections of CTD dossiers including justification of specifications and impurity profiling
- Collaborate with cross functional departments including R&D, QC, QA, Regulatory Affairs, and Production
- Oversee raw material analytical methods verification and validation
Requirements
- Experience in analytical method development, validation, transfer, and stability studies
- Knowledge of ICH, USP, GLP, and regulatory requirements
- Experience with 21 CFR Part 11 compliance and data integrity
- Proficiency in chromatographic systems (HPLC/GC)
- Experience with OOS/OOT investigations and trending
- Strong technical writing and documentation skills
- Ability to provide technical guidance and training
Full Job Posting
Role Overview
- This role is responsible for overseeing analytical method development, validation, transfer, and stability studies in compliance with ICH, USP, GLP, and regulatory requirements.
- Ensures data integrity, 21 CFR Part 11 compliance, and robustness of analytical systems across QC laboratories.
- Provides technical leadership for investigations, regulatory submissions, and audit readiness while collaborating cross functionally to support product development and commercialization.
- Drives continuous improvement in laboratory compliance, analytical performance, and team capability.
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.
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