Ganesh Reddy

• Near 5.0 years of Experience in Sterile Production cleaning , equipment validations and manufacturing activities using regulatory guidelines and scientific approaches and audit compliance. • Expertise in risk assessment, process developments, manufacturing filling lines validations and continuous compliance and Quality systems and manufacturing process. • Excellent Practical, troubleshooting and inter-personal skills with proven ability in driving numerous quality enhancements, process improvement and cost savings initiatives during the career span. • To prepare and Review, Execution of cleaning validation and process validation protocol of General, General Parenteral.. • To prepare and execution of hold time study protocol and summary report. • To monitor the processing steps and to carry out process validation sampling and hold time sample as per approved protocol. • Prepare cleaning project validation plans and responsible for executions in time. • Internal auditing of validation deliverables • Preparation of QRM’s for equipments and process validation batches. • Qualification (IQ/OQ/PQ) of Manufacturing Equipments which includes vial washing M/c, tunnel, Autoclaves, filling and sealing Equipments. • Qualification of BOD incubator, automatic visual inspection M/C(Breveti). • All MQA/ in process activities for manufacturing process.