Senior Quality Assurance Specialist
4 weeks ago
Job Summary
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Hydrogen Group. The successful candidate will work closely with our GDP Operational QA Management team to ensure the distribution of medicines in the USA complies with GDP and GMP requirements.
Key Responsibilities
- Manage and maintain Quality Agreements, KPIs, deviations, CAPAs, and change controls.
- Oversee Finished Goods release at 3PL and ensure compliance with distribution requirements.
- Support New Product Launches, Clinical QA distribution, recalls, and market activities.
- Provide regulatory inspection support and post-inspection follow-ups.
- Manage event investigations, CAPAs, and customer complaints.
- Maintain the Quality Management System (QMS) and ensure compliance with regulations and licensing.
- Engage in self-inspections and approve subcontracting activities.
- Create and approve Standard Operating Procedures (SOPs) and quality documents.
Requirements
- Master's degree with 3-5 years or Bachelor's degree with 5+ years of relevant experience.
- Strong background in GDP/GMP, auditing, interpersonal skills, and fluency in English.
- Proficiency in Microsoft Office is required.
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