In this role, a typical day will include:
· Conduct ongoing process verification(OPV), statistical analysis, and data trending to monitor product quality and manufacturing performance.
· Develop and maintain Quality Risk Analyses (QRA), ensuring effective monitoring of critical process parameters and quality attributes.
· Identify process deviations, quality risks, and improvement opportunities through data-driven analysis.
· Support continuous process optimization and ensure products remain in a validated state of control.
· Communicate process performance trends and key findings to relevant stakeholders.
· Support technical transfer and batch scale-up activities, providing process expertise to ensure successful implementation at site level.
· Coordinate project execution, including scope, timelines, feasibility studies, regulatory and validation batches, while monitoring overall progress.
· Prepare manufacturing process transfer documentation and manage change controls through approval, implementation, and closure.
· Prepare and review the PQR data and provide the correct level of discussion on it.
· Execute and support process validation, revalidation, and continuous improvement activities to ensure manufacturing processes remain compliant and in a validated state.
· Prepare, review, and approve validation protocols, reports, and supporting documentation to ensure technical accuracy and regulatory compliance.
· Coordinate cross-functional validation activities, including testing, study execution, documentation, and stakeholder alignment to achieve project objectives.
· Manage and support change control processes, assess proposed process changes, and ensure timely implementation, approval, and closure.
· Drive process optimization and technical improvement initiatives through data-driven analysis, investigation of process-related issues, and evaluation of critical process variables.