V. Sankar Ananth

• Selection & Preparation of Technical Specifications for Analyzers, Instruments Data Sheets
• Technical Requisition, Technical evaluation of Bids, Technical Queries generation
• Preparation of Technical comparative statement of Field Instruments, Control System
• New Projects discussions and attending Technical meeting with client and Negotiation
• Providing Technical Support Start from installation to Service.
• Proved successful working within tight deadlines and fast-paced atmosphere.
• Led projects and analyzed data to identify opportunities for improvement.
• Resolved problems, improved operations and provided exceptional service.
• Increased customer satisfaction by resolving the technical issues.

• Performed CSV at biocon laboratory equipment’s/instruments.
• Participated in meetings with IT Project Manager, Validation Analyst in order to track project status and to verify the project progress complies with the project schedule
• Expertise in conducting Risk Assessment, 21 CFR Part 11 Assessment, Security Assessment, and documenting as per GAMP 5 guidelines
• Heavy emphasis on Computer Systems Validation, Instrument/Equipment Validation
• Prepared and Reviewed the CSV documents such as start from QPP (Quality Project Plan),to VR (Validation Report)
• Responsible for handling the objective evidence, managing the associated deviations and escalating the system issues
• Performed and documented CSV activities of QC instruments
• Involved in Effective implementation of the QMS ,System documentation procedures like Change controls, Deviations, investigations, Incident reporting etc and verification of CAPA taken as a compliance measure
• Coordinated with project activities and achieved the goal as per timeline.
• Trained and guided onsite and offshore team members in quality assurance standards, policies and procedures.

• Leading an Engineering Instrumentation/Automation team (SME,SPA) Maintenance, Calibration, qualification, validation, compliance & investigation for entire site facility & management representative(SME,SPA) from engineering Instrumentation department for, procurement, CAPA, Event management meetings and part of audit (Internal & external) response team
• Ensuring the department training, development and compliance.
• Developed team communications and information for meetings.
• Created plans and communicated deadlines to ensure projects were completed on time.
• Owning the Change control and ER, and CAPA including the Audit observation points and supporting CFT events and CAPA related to Instrumentation engineering department
• Performing and Ensuring engineering practices and procedures aligned with applicable PQS(Pfizer Quality standards)procedures guidelines,GxPs (GMP and GDP)
• Monitoring the status on Engineering activities, such as ER’s, CAPAs, change controls, and ensuring the quality and accuracy of documentation and alignment to due dates as per the target
• Performed Remediation activities and risk assessments related to the USFDA & MHRA audit observations
• Hands on experience Spare procurement, Vendor evaluation and qualification process
• Interacted & Coordinated with Central project & QA team regarding documentation & validation activities during external & internal audits.
• Coordinated with all Project Engineers & Contractors for the site execution work for day-to-day activities
• Performed and executed the CSV assessment and Computer System Validation (CSV) for process equipments with my engineering team
• Performed duties in accordance with applicable standards, policies and regulatory guidelines to promote safe working environment.
• Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.

• Leading an Engineering Instrumentation/Automation team Maintenance, Calibration, qualification, validation, compliance & investigation for entire site facility & management representative from engineering Instrumentation(SME,SPA) department for, procurement, CAPA, Event management meetings and part of audit (Internal & external) response team
• Ensuring the department training, development and compliance
• Orchestrated the expansion projects within strict timeframes and budget constraints by solving complex problems and working closely with senior leaders.
• Reported regularly to managers on expansion project activities, progress and technical problems.
• Coordinated and conducted the Internal and External audit team and providing the response as per the audit schedule
• Coordinated with CFT (Cross Functional Team) to carry out change controls and Investigations for Engineering which includes all the operations qualifications, safety and compliance
• Performed engineering practices and procedures aligned with applicable PQS(Pfizer Quality standards)procedures guidelines,GxPs (,GMP and GDP) and optimization of Sop's and provide the report to manager
• Handled comprehensive corrective and preventive (CAPA) management system, Change control(author and Reviewer) , related to Instrumentation engineering department
• Performed Remediation activities and risk assessments related to the USFDA & MHRA audit points
• Hands on experience Spare procurement, Vendor evaluation and qualification process
• Reviewer and approver responsibility for Protocol documentation, such as URS,DQ, IQ, OQ & PQ for the process Equipment as per USFDA cGMP, EU, ISO standards & requirements
• Interacted & Coordinated with project & QA team regarding documentation & validation activities during external & internal audits
• Hands on experience in preparation of new SOP's, PMSOP's, EOP's and IOP's in Pdoc's
• Collaborated successfully with cross-functional development teams to design and manufacture new products.

• Leading Instrumentation team(SPC), maintenance of Mammalian, Fill finish area Equipment’s, Centralized Utility area(water Systems, Boiler ETP,STP,MEE), and Quality Control area instruments maintenance and Validation
• Aligned organizational objectives with company mission, increasing revenue, profit and business growth by collaboratively developing integrated strategies.
• Resolved issues and recommended actions based on production and compliance reports.
• Reviewed and Approved Instrumentation engineering related Documents generated by the Vendors
• Coordinated in Syngene international (S2) pharmaceuticals plant activities.
• Participated as a SME in multiple Internal and External audits
• Plant Maintenance in API & Formulation Area:
• Identification of problems in critical equipments and finding the root cause and providing the cost effective solutions
• Ensuring the department training, development and compliance
• Preparation of Specifications for all field instruments
• Ensuring the Maintenance, calibration upstream and Downstream equipments/instruments
• Hands on experience in Allenbradley,Siemens,Danfoss,Omron industrial drives.
• Qualification and validation of production, watersystem and Quality equipments
• Ensuring the Maintenance, calibration fill finish area equipments and instruments till packaging and warehouse
• Experience in Johnson control BMS Systems Metasys server with N2 bus communication modules.
• Ensuring the Temperature mapping activities as per the schedule
• Completed the project in utility areas field instruments with connected to the DX-200P Yokogawa make data logger and Qualification
• Participated Multiple External audits.
• Participated in FAT in Alfalaval centrifuge in Sweden and Sartorius bioreactors 2kl, SAT, Installation & Commissioning.
• Reviewed individual department performance and worked with leadership to improve processes, procedures and practices.
• Established performance goals for department and provided methods for reaching milestones.
• Employed optimal safety practices to reduce work site complaints, hazards, incidents or lost-time accidents to improve overall OSHA scores and expand bid opportunities.

• Project and Maintenance in Chemical synthesis Plant:
• Coordinating Biocon Park Greenfield Project Erection, Commissioning and maintenance of Chemical Synthesis Plant Controlled by DCS
• Ensuring Maintenance and calibration of Chemical Synthesis Plant instruments
• Ensuring the department training, development and compliance., Member in the Instrumentation Team for Erection and commissioning of Sugar and power plant.
• Trained employees on safety and project procedures.
• Collaborated with on-site directors, operations managers and supervisors on engineering projects.
• Inspected third part equipments/Instruments before, during and after projects to maintain progression and functionality.
• Completed over 80 numbers of Reactors with instruments installations with vendors during projects consistently sticking to strict schedules and budgets from start to finish.
• Completed the Profibus network communication establishments activities with third party equipments and ABB DCS Systems.

. Monitored installation and operations to consistently meet rigorous customer requirements.

. Worked as a Core Project Member in the Instrumentation Team for Erection and commissioning of Sugar and power plant.

• Maintenance of 4.5 mw DCS controlled Boiler, turbine, watersystem and other equipments /instruments
• Trouble shooting and maintenance of pneumatic and electronic process control equipment and all field instruments
• Coordination and Supervision for the execution of the Evaporator plant
• Resolved problems, improved operations and provided exceptional service.