Chemist for Validation and Calibration

Description

Position Summary: Implement and maintain validations and qualifications to ensure consistent product quality, and develop the master validation plan and validation protocols. Key Highlights: 1. Key role in quality assurance and process validation. 2. Leadership in developing validation plans and protocols. 3. Coordination of instrument calibration activities. Position: Validation Chemist Position 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: B.S. in Chemistry, Industrial Chemistry, or related field Years of experience in position: Minimum 1 year Gender: Not specified Marital status: Not specified KNOWLEDGE IN: **GLP: Good Laboratory Practices.** **GDP: Good Documentation Practices.** **Statistics** **Equipment and area qualification** **Process validation** **FEUM** **Familiarity with NOM-241-SSA1-2021: GMP for medical devices.** **Familiarity with 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.** Employment type: Full-time, Indefinite term Salary: $9,451.20 - $10,000.00 per month Work location: On-site employment