Quality Specialist

Description:

• Oversee quality aspects of onsite manufacturing, internal materials management, warehousing, and quality control testing with management support.
• Manage quality oversight for operational activities at approved outsourced service providers, including QC testing and material management.
• Prepare and review Quality Agreements and monitor Supplier GxP compliance.
• Review batch documentation and provide subject matter expertise for key Quality systems.
• Lead or facilitate Quality Risk Management activities in line with industry standards.
• Support QA leadership in document preparation and review for release activities.
• Provide oversight for continuous quality system improvements and support implementation in various GxP systems.
• Offer QA and compliance support for projects impacting manufacturing activities.
• Provide expertise for inspection readiness activities and regulatory inspections.
• Review and approve Master Batch Records in compliance with internal procedures and GMP principles.
• Review and approve Standard Operating Procedures and controlled documents.
• Define and drive standard quality KPIs and recommend improvement actions.

Qualifications:

• 3-5 years of experience in cGMP Pharmaceutical Operations, including direct involvement with Quality systems.
• Bachelor's degree in a scientific discipline or equivalent.
• Ability to work independently and flexibly in a startup environment, fostering a high-performance Quality culture.
• Experience in Supplier Quality oversight activities is advantageous.
• Experience in Quality Risk Management, particularly in leading or facilitating QRM activities, is beneficial.