Senior Executive - Quality Assurance

As a Computer System Validation & QA-IT professional, your role involves various responsibilities related to process activities. Some of the key responsibilities include: - Reviewing Qualification and Re-Qualification protocols & reports. - Reviewing Preventive Maintenance & Calibration records. - Reviewing and approving critical consumable items. - Monitoring engineering & utility services such as facility layouts, building layout, material flow, HVACs, Nitrogen plant generation and distribution, purified water generation and distribution, and Equipment qualification. - Reviewing breakdown maintenance system. - Handling SAP activities for Engineering. - Managing new product introduction at the site. - Overseeing technology transfer documents. - Conducting development activities and reviewing development reports. - Reviewing Scale-up reports. - Preparing for audits and ensuring readiness. - Conducting Hold time studies and monitoring stability study initiation. - Managing Nitrosamine and Genotoxic impurity-related reports. - Providing support to Regulatory Affairs for submission purposes. - Preparing and reviewing Cleaning validation protocols, templates, and reports. - Evaluating Cleaning matrix. - Preparing and reviewing process validation protocols, templates, and reports. - Compiling and submitting data for the preparation of Monthly/Quality metrics reports. - Reviewing draft master BMR in software and filled BMR related to validation. - Evaluating the qualification of outside testing/service contracts with external agencies. - Performing other activities as instructed from time to time. Please note that the above responsibilities are crucial for ensuring the smooth operation and compliance of the systems and processes within the company.,