What are the responsibilities and job description for the Product Quality Assurance Specialist position at Avantor?
Job Summary:
As a Product Quality Assurance Specialist at Avantor, you will lead efforts in site quality assurance programs and improvement activities to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations, and FDA requirements. Your key responsibilities will include identifying and implementing programs to ensure regulatory compliance, supporting CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC, and Validation systems.
About This Role:
We are seeking a highly skilled and experienced Regulatory Compliance Manager who can provide GMP and GDP training to site personnel and collaborate with supplier quality personnel to resolve quality-related issues. You will partner with external customers, operations leadership, and plant operations teams to investigate and resolve process and product quality issues.
What You Will Do:
As a Product Quality Assurance Specialist at Avantor, you will lead efforts in site quality assurance programs and improvement activities to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations, and FDA requirements. Your key responsibilities will include identifying and implementing programs to ensure regulatory compliance, supporting CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC, and Validation systems.
About This Role:
We are seeking a highly skilled and experienced Regulatory Compliance Manager who can provide GMP and GDP training to site personnel and collaborate with supplier quality personnel to resolve quality-related issues. You will partner with external customers, operations leadership, and plant operations teams to investigate and resolve process and product quality issues.
What You Will Do:
- Develop and implement quality assurance programs and procedures to ensure regulatory compliance.
- Lead customer complaint investigations and manage audit activities to identify areas for improvement.
- Collaborate with supplier quality personnel to resolve quality-related issues and improve supply chain reliability.
- Partner with external customers, operations leadership, and plant operations teams to investigate and resolve process and product quality issues.
