Mahesh C

Review and/or assist in developing validation strategies and associated documentation against the requirements of Biocon’s CSV Policy and procedures, as well as the Validation Master Plan (VMP) to ensure that compliance and business needs are achieved.
Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects.
Development of Validation Plan, Requirements Traceability Matrix, Risk Assessment, IQ/OQ/PQ Study Protocols, Validation Summary Report, Change control, SOPs.
Coordinate and manage validation and qualification testing documentation review, approval signoff, execution, and post-execution review
Review & provide input, where required, to CSV-related Standard Operation Procedures (SOPs) and/or policies, and ensure adherence to internal SOP’s and regulatory requirements.
Expertise in conducting Risk Assessment, 21 CFR Part 11 Assessment, Security Assessment, and documenting as per GAMP 5 guidelines.
Supported compliance audits by presenting and answering questions for qualification documents during FDA, corporate and product acceptance inspections.
Responsible for maintaining Equipment related documentation for Audit purpose.
Initiated, controlled and executed validation processes and procedures for engineering as required by the FDA.
Developed challenge points for the control system executed and prepared summary report by working with the CQA team.
Hands on working experience in Emerson Delta V DCS.
Knowledge of SCADA architecture client-server and Server redundancy configuration.
Perform process control philosophy and stability reviews coupled with execution of control logic update.
Knowledge in using Devicenet, real-time ethernet, PROFIBUS (DP & PA) and Foundation Fieldbus protocols.
Planning of manpower and spares according to plant requirements and monitoring of plant instrument workshop.
·        Responsible for calibration activity of the field instruments and maintaining the reports as per cGMP.