Job Description
Responsibilities
- Design, develop, and optimize manufacturing processes.
- Implement improvements in efficiency, quality, and cost using Lean Manufacturing, Six Sigma, and Design of Experiments (DOE) methodologies.
- Prepare and execute process and equipment validation protocols (IQ/OQ/PQ) according to regulatory requirements.
- Define, control, and monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
- Investigate process deviations and lead Corrective and Preventive Actions (CAPA).
- Coordinate technology transfer activities from R&D to manufacturing.
- Develop and maintain technical documentation such as work instructions, process flow diagrams, validation reports, and SOPs.
- Participate in internal and external audits (FDA, ISO, COFEPRIS, or other regulatory bodies).
- Ensure full traceability of materials, equipment, and production batches in compliance with medical ...