Validation and Calibration Chemist

Description

Position Summary: Implement and maintain validations and qualifications to ensure consistent product quality and the instrument calibration program. Key Responsibilities: 1. Development of the master validation plan and validation protocols. 2. Reporting and communication of validation and qualification results. 3. Coordination of instrument calibration activities. Position: Validation Chemist Job Description: **Implement and maintain necessary validations and qualifications to ensure that the process consistently yields a product meeting its quality attributes.** Implement and maintain the instrument calibration program. Specific Objective: **Develop the master validation plan.** **Develop validation protocols for analytical methods, process validation, and equipment and system qualification.** **Report and communicate validation and qualification results.** Coordinate activities to comply with the instrument calibration program. Profile: Education: Industrial Chemist, Chemical Engineer, or related degree. Years of experience in the position: Minimum 1 year. Gender: No preference. Marital status: No preference. KNOWLEDGE IN: **GLP: Good Laboratory Practices.** **GDP: Good Documentation Practices.** **Statistics** **Equipment and facility qualification** **Process validation** **FEUM** **Knowledge of NOM\-241\-SSA1\-2021: GMP for medical devices.** **Knowledge of NOM\-137\-SSA1\-2008: Labeling of medical devices.** **Knowledge of ISO 9001:2015 Quality management systems.** **Knowledge of ISO 13485\-2016 Quality management for medical devices.** Type of position: Full-time, indefinite term. Salary: $9,451\.20 \- $10,000\.00 per month. Work location: On-site employment