
GxP Quality Specialist
11 hours ago
Job Overview:
We are seeking a Quality Specialist to join our team. This role will be responsible for ensuring the quality of our products and processes.
Collect, monitor, and report Key Performance Indicators (KPIs) for management reporting.
Assist in Health Authority inspections and internal audits by providing timely information and documentation.
Support the implementation of local Quality systems in accordance with our Quality Manual.
Manage processes and systems for GxP Quality Assurance, including Change Control, Training Management, Escalation Management, and Risk Management.
Ensure compliance with GxP standards.
Contribute to process improvements and implementations.
Track and complete corrective and preventive actions (CAPA), escalating issues as necessary.
Review quality deliverables for compliance with health authority requirements and SOPs.
Prepare and review GxP documentation, assisting with release and archiving.
Support Compliance reviews and inspection readiness.
Report technical complaints, adverse events, and special case scenarios within 24 hours.
Distribute marketing samples, if applicable.
Key Responsibilities:
Maintain sound working relationships with partners and customers.
Lead specific initiatives and engage early with external/industry stakeholders.
Model industry culture, values, and behaviors within your department.
Requirements:
Functional breadth, collaborating across boundaries, operations management, and project management expertise.
Agility, audit management, business partnering, change control, continuous learning, influencing skills, knowledge of CAPA, QA, quality management, QMS, risk management, root cause analysis, self-awareness, SOP, and technological expertise.
Proficiency in English language.
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