Kumar Kommukuri

A competent and committed professional with a career success of over 22 years, positioned as Team Lead, Engineering with Dr. Reddy's Laboratories Limited.

Competencies in the quality and production (downstream) domain, including qualifications, maintenance activities, quality audits, quality management systems, and investigations documentation, in conformance with domestic and international guidelines.

Weorked in API Unit 1, Unit 2, Unit 3, FTO Unit 1 and Biologics as engineer - Analytical & Process equipments

Responsible and SPOC for maintenance activities in the QC lab.

. Responsible for the maintenance of analytical equipment in manufacturing facilities and R&D facilities.

● Qualification of instruments according with GAMP5 and 21CFR part11 requirements.

Establish the procedures in accordance with global requirements for the engineering operations.

Implementation of a digital process for maintenance activities (app-based breakdown and preventive maintenance activities).

Responsible for the Instrument & software upgrade activities and to ensure completion with in Manufacturing timelines

Responsible for planning and execution of Product change over activities to Process chromatography systems

Streamlining the maintenance activities across the labs to inline with User requirements and calibration schedules.

Conducting root cause analysis of customer complaints, taking preventive and corrective action to rectify the same, and ensuring timely and speedy customer satisfaction.

· Chromatography soft wares such as Waters Millennium, Empower and Agilents Chemstation.

Handling of Administration activities for All non computerized systems across labs.

· Have good knowledge on Empower Network software , chem. Station and EZ chrom and Lab solutions software.

Co ordination with vendors for smooth execution of calibrations

Member of GSK EAS – CDS support team, managing Empower and LIMS software applications.

Managed technical support for Waters Empower Chromatography software and LIMS support

Managed Empower software concerns raised by users and delivered effective solutions.

Support the planned outages.

• Maintained up-to-date knowledge of software and technical developments through reading and training.

• Collaborated with Discovery Research, Generics (FTO3), and Custom Pharmaceutical Services as Analytical Instrument maintenance engineer.
• Installation's & Maintenance of all models of HPLC's ( Waters, Agilent, Shimadzu) GC's,(Agilent, Shimadzu), LC-MS/MS (Applied Bio systems, Waters) UV Spectrophotometers( Perkin Elmer, Shimadzu), Fourier Transform Infrared Spectrophotometer's (FTIR) (Perkin Elmer,Shimadzu) Auto Titrators( Mettler, Metrhom) Analytical Balances( Mettler and sartorious), pH meters, Centrifuges, with Auto samplers, Particle Sizing Systems, DSC (Shimadzu, TA) and all other Analytical Equipment's of Entire Plant.

· To ensure and perform preventive maintenance for all Lab equipment

· To perform & responsible for Equipments qualifications and calibrations

· Lab compliance towards FDA regulations and part 11 compliance

· To perform training to the people on trouble shooting, do’s & don’ts

· To perform Administration responsibility for instrument control software’s,

· Responsible for Purchase coordination, service coordination, Planning,

· Spares Inventory , Annual maintenance contracts ( if required)