
Senior Quality Assurance Specialist
2 weeks ago
System Engineer - Quality Management Specialist
We are seeking an experienced professional to design and implement Quality Management systems that meet regulatory requirements.
Key Responsibilities
- Implement Quality Management systems, including Master control/ETQ/CEBOS, to ensure compliance with GMP and FDA regulations.
- Configure MRP systems and manufacturing concepts to optimize production processes.
- Work with technical teams for integration with different applications and provide training on system use.
- Create design specifications based on customization needs and develop validation documents like Process Qualification (PQ) and Installation Qualification (IQ).
- Build and promote customizations to QA and PROD environments.
Requirements
- 3-7 years of experience in services in a technical/configuration field.
- Experience with Good Manufacturing Practices (GMP), FDA, ISO 9000, Current Good Manufacturing Practice (cGMP), and FDA Regulations.
- Strong problem-solving ability, strong manufacturing or business process knowledge, and excellent writing and communication skills.
Preferred Qualifications
- Programming concepts and experience with Crystal reporting/Tibco Spotfire.
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