Quality Engineer-Pharmaceutical

Qualification:

• Bachelor's degree in any Engineering domain.
• 1 years Experience working in a quality role (QMS development, implementation, and/or execution) within a manufacturing environment.)
• Strong knowledge of ISO and cGMP requirements and relevant industry standard practices
• Must have ability to interpret these regulations to ensure proper implementation in the plant systems
• Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment
• Digital solution development skills and understanding of systems, data integrity and data creation

Responsibilities:

• Lead and/or support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
• Document control and review/approval of controlled documents
• Change management and review of change controls
• Investigation and CAPA management, including robust root cause analysis
• Complaint management and performance of complaint investigations
• Supplier quality management and performance of supplier audits as appropriate
• Internal audit program and performance of internal audits
• Training program; conduct training when needed
• Implementation of Quality Risk Management in relevant aspects of the QMS
• Management Review
• ISO certification and maintenance
• Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management
• Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product
• Customer support, including:
• Support customer audits, including response and corrective action tracking
• Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication

Thanks

Suchi

suchi@vastekgroup.com

203-446-4148