Key Responsibilities
Quality System Management
* Act as theQA SMEfor PQS systems, including deviations, change control, complaints, validation, and risk management.
* Review and approve Standard Operating Procedures (SOPs) and other controlled documents.
* Author and develop assigned QA SOPs and documentation.
* Provide QA oversight for operational activities at approved service providers (QC testing, material storage, supply).
* Lead or facilitateQuality Risk Management (QRM)activities in line with ICH Q9 rev1.
* Identify and implement continuous quality system improvements.
Batch Documentation & Release Support
* Provide guidance on master batch documentation development.
* Review and approve executed batch documentation.
* Assist QA leadership and Qualified Person (QP) teams in documentation preparation for release activities.
Supplier & Manufacturing Oversight
* Provide QA oversight for on-site manufacturing, materials management, warehousing, and quality control testing.
* Prepare and reviewQuality Agreementsfor service providers.
* ConductSupplier GxP Monitoringduring onboarding and throughout the lifecycle.
Regulatory Compliance & Inspection Readiness
* Execute assigned inspection readiness activities.
* Participate in regulatory inspections, interact with inspectors, and contribute to responses and follow-ups.
Experience & Qualifications
Essential Requirements:
* Minimum3 years of experienceincGMP pharmaceutical operationswith direct exposure to quality systems.
* Degree in a scientific disciplineor equivalent qualification.
* Ability to workindependently and flexiblywhile fostering a high-performance quality culture.
Preferred Experience (Advantageous):
* Supplier Quality Managementactivities.
* Quality Risk Managementexperience, particularly in leading or facilitating QRM activities.
* Knowledge ofGood Distribution Practice (GDP).
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