Chief Quality Excellence Officer

2 days ago

Kota, Rajasthan, India beBeeQuality Full time ₹ 18,00,000 - ₹ 25,20,000
Job Title: Head of Quality Assurance

As a senior leader in the quality assurance department, you will be responsible for ensuring that all aspects of our operations meet the highest standards. This includes developing and implementing quality audit procedures, maintaining robust quality systems, and ensuring compliance with regulatory requirements.

The ideal candidate will have extensive experience in quality assurance, with a strong background in regulatory compliance and quality management systems. You will be responsible for coordinating vendor qualification activities, performing internal audits, and ensuring that all products meet the required standards.

You will also be responsible for developing and maintaining a robust quality management system, including change management, deviation management, incidents, complaint handling, and CAPA management. Additionally, you will oversee investigations of non-conformances, handle product recalls, and create and maintain systems to implement ICH Q8, ICH Q9, and ICH Q10 requirements.

A successful candidate will be well-versed in cGMP requirements and quality standards, with excellent leadership and communication skills. You will work closely with cross-functional teams to ensure that the company maintains a state of readiness for inspection by regulatory agencies.

You will be responsible for leading and managing quality-related initiatives, providing quality guidance to product development projects, and ensuring data integrity through internal audits, training, and review.

The position requires a strong understanding of injectable products, facility requirements, and media fill requirements. You will also be responsible for technology transfer documents, compiling records, and ensuring smooth transmission to meet regulatory requirements.

You will ensure the development of departmental SOPs, writing, revising, and approving them to ensure regulatory compliance and fit-for-purpose operationally and commercially.

The ideal candidate will have excellent organizational and time-management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.

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