GxP Quality Specialist

11 hours ago


Hyderabad, Telangana, India beBeeQuality Full time ₹ 18,00,000 - ₹ 2,13,10,000

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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