Saravanan Murthy Email & Phone Number

Chennai, Tamil Nadu, India

Experience in regulatory requirements and documentation as Risk Impact Determination, Validation Plan, Test approach, Test Plan, Test report (System, Integration and UAT), Requirement Traceability Matrix (RTM), Validation report, Cutover report etc.Experienced in the tools such as SAP SolMan for Change Management, SharePoint managing the Project level documents and Test reports & ServiceNow for maintaining CMDB system profile.1. Accountable for review and approval of change documents for all the SAP systems.Ensuring the findings raised from Quality review are addressed appropriately and closed on time.2. Provide guidance/feedback to the project teams related to validation processes as per the applicable regulatory requirements.3. Identifying and escalating Quality Incidents and process deviations to the respective stakeholders, analyzing, investigating and following-up of quality issues and perform effectiveness checks on CA/PAs.4. Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation.5. Review and approval of Change documentation using solution manager module of SAP with respect to business process for any changes in SAP system.

Chennai, Tamil Nadu, India

1.Hands-on experience for preparing Test Plan, Test Cases, Defect Report, Objective Evidence and Test Summary Report2.Hands-on experience in Verification and Validation testing (OQ and PQ) in Life sciences industries with USFDA regulations (21 CFR Part 11, 21 CFR Part 820) and GAMP4, GAMP5, GDP.3.Hands on experience in Polarion tool (ALM), QDMS (Document Repository tool, DocuSign (Objective Evidence and Test Log creation)4.Hands on experience on Software Validation Applicability assessment, Requirement Traceability Matrix.5.Have good co-ordination with business, development and functional team members during Project Life cycle for performing V&V activities.6. Review of all deliverables such as Validation plan, Validation Report, Test strategy, IQ, OQ and PQ specifications.7.Hands-on experience in System Periodic review, URS, FRS/FRA and DS for the Life sciences and the ERP applications.

Bangalore

• 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.• Involving in conducting Risk Assessment, 21 CFR Part 11 Assessment, Security Assessment, and documenting as per GAMP 5 guidelines.

Chennai Area, India

Bangalore

Responsibility to Prepare and check the field instrument datasheets, Index, IO list, Instrument process datasheets based on the inputs available from P&IDs, design criteria, technical specifications etc.• Responsibility to check hook-up drawings for various Field instruments.• Co-ordinate with Designer for modeling activities such as Instrument cable tray routing, location of system related panel in Control rooms and field.• Co-ordination with Piping to locate and install the inline field instruments based on the codes and standards, technical specifications etc.•DCS system starts up testing, FCS CPU Project back up loading and testing- Verification of P&ID and preparing the functional sequence description- System graphics, Logics and alarm modifications according to the process requirements- Implementation of PID controller for boiler open and closed loop systems- Implementation of report packages, alarm management, trend & historical reports- Knowledge & implementation of Sequence of Events (SOE) Function- Experience with protection and interlock checking, Forcing Io’s and checking the status- Knowledge & implementation on Sub system communication using PROFIBUS & MODBUS- Knowledge on OPC communication between DCS and other third party systems- Trouble shooting of DCS hardware equipment’sNature of Job Involved with Field Instruments:- Operation, Maintenance, Calibration, Troubleshooting & Loop checking of field Instruments such as Control Valves, P.I.D. Controllers, Pressure Transmitters, Pressure switches, Pressure gauges, Flow Transmitters, Level Transmitters, sensors & Temperature Transmitters using RTD’S & Thermocouple’s- Preparation for Preventive, Predictive, Breakdown and Annual shut down maintenance planning and reports etc., for various field instruments and Control systems

Puducherry Area, India

Bachelor'S Degree, Electronics And Instrumentation, B.E

Xii Th Std, Computer Science

Activities and Societies: School Cricket Captain,Involved In District Level Carrom Board Matches,Won Prizes in Drawing Competitions