Process Technology and Quality Manager

Responsibilities :

• Scope of responsibility includes managing the process and quality activities for all production and plant cGMP activities.
• Collaborate closely with all plant and local R&D functions to ensure quality, process capability and production performance.
• Manage and develop both the Quality Assurance and Process Technology team.
• Be the primary point-of-contact for quality issues and projects, leading QA activities to ensure the quality of raw materials, of finished goods and the production process capability.
• Manage and coordinate the technical process activities associated with plant operations to ensure safe, environmentally compliant, efficient, and high-quality outcomes.
• Apply statistical process controls to assist operations with assuring production processes remain in control and product is meeting specifications.

Requirements :

• Bachelor’s degree in chemical engineering or related field.
• 7+ years of experience in one of the following : chemical plant operations, project management, or process design engineering.
• Demonstrated experience with QMS, FDA and cGMP programs and compliance.
• Proficient using process technical tools and software.
• Ability to lead Front End Planning, detailed design and construction on process facility projects.
• Strong understanding of batch operations, solids handling and blender operations.
• Six sigma certification is highly preferred.
Hace 4 días