VALIDATION ANALYST 2

Description

Job Summary: Professional responsible for validating production and cleaning processes, ensuring compliance with BPM/GMP and sanitary regulations, along with statistical analysis and quality management. Key Highlights: 1. Experience in validation of production and cleaning processes. 2. Participation in statistical analysis and quality management. 3. Ensuring compliance with BPM/GMP and regulatory requirements. Pharmaceutical chemists, chemical engineers, and/or related disciplines. Experience in: Process Validation Participate in the execution of validations and revalidations of production processes. Perform statistical analysis of validation results (trends, variability, acceptance criteria). Develop and review: Process validation protocols, Validation reports, Verify compliance with critical process parameters (CPP) and critical quality attributes (CQA). Support identification and evaluation of process risks (FMEA or other methods). Cleaning Validation Execute cleaning validation and revalidation activities. Define and evaluate: Acceptance limits (MACO, PDE, NOEL, L0/L1/L2 as applicable), Critical points and worst-case scenarios. Analyze sampling results (swabs, rinses). Develop and review cleaning validation protocols and reports. Support management of deviations associated with out-of-specification results. Quality Management Record and analyze deviations, change controls, and CAPA related to validations. Maintain up-to-date documentation of the validation system. Ensure compliance with current BPM/GMP and sanitary regulations. Support internal and external audits, as well as regulatory authority requirements. Employment Type: Full-time Work Location: On-site employment