Key Responsibilities

Quality System Management

• Act as the QA SME for 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 facilitate Quality 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 review Quality Agreements for service providers.
• Conduct Supplier GxP Monitoring during 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:

• Minimum 3 years of experience in cGMP pharmaceutical operations with direct exposure to quality systems.
• Degree in a scientific discipline or equivalent qualification.
• Ability to work independently and flexibly while fostering a high-performance quality culture.

Preferred Experience (Advantageous):

• Supplier Quality Management activities.
• Quality Risk Management experience, particularly in leading or facilitating QRM activities.
• Knowledge of Good Distribution Practice (GDP).