Responsible to provide guidance for all aspects of formulation/process development, scale-up manufacture submission/registration batches with efficient utilization of time/resources and proven successful tracking records.
Perform Preventive maintenance and trouble shooting for all the utility of the facility including Air Handler, Chillers and Steam line.
Monitoring of the utility of the facility.
Monitoring and familiar with operations of the Building Automation system.
Identifying the part and requesting the purchase order.
Develop and validation analytical method for drug substances, drug products, and excipients
Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.
Write protocols, reports, methods, standard operation procedure, and submission documents.
Responsible for the oversight, reporting and monitoring of company's quality systems, including investigations, corrective actions (CAPA), training programs. Responsible for the improvement of existing systems and the development of new quality systems.