Balaji Rao Gorle

I am a purposeful Lead Digital Specialist (Business Consultant) with a focus on quality management with Extensive experience in developing and implementing quality processes to enhance operational efficiency and customer satisfaction. Skilled in conducting audits, analyzing data, and providing strategic recommendations to improve business performance. Adept at collaborating with cross-functional teams to achieve quality objectives and drive continuous improvement initiatives.

• USFDA
• MHRA
• China FDA
• TGA

Acting as a site SPOC from Digital Process Excellence Team for the implementation & Trouble shooting  of LabWare LIMS application, Empower, RPACD and adoption along with all quality use cases., 

Collection of user requirements from Business and implementation., 

Acting as a Product Owner for creation and development of dashboards (Ex: QC-VSM, Central Inventory System Dashboards)., 

Enhanced digital strategies by analyzing data to improve TAT reduce the Incidents., 

Responsible to digitalize the all core areas of quality control and Quality Assurance with agile manner., 

Business engagements with site leadership on new digital products., 

Accountable that assigned projects implement security and compliance with regulations like CSV and Agile project methodology.,

Trouble shooting of all instruments and software related issues., Demonstrating the value of quality products and services to the project team for increased adoption and adherence., 

Responsible to Train and coach teams on quality aspects of system life-cycle processes, quality standards.,

Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems within regulated environments., Documented entire validation process, noting changes or alterations completed., 

Led the training of junior team members on validation principles and techniques, fostering a culture of continuous learning within the organization., Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed., Preparation of validation deliverables like URS, Validation Plan, Validation Report, IQ/OQ/PQ Protocols and reports, RTM & Release certificate., Qualification of laboratory Instruments /Equipment's and Validation of software's as per Computer System Validation (CSV) procedure., Management of Laboratory instruments (Calibrations /Preventive Maintenance scheduling, planning and closing)., Investigation of laboratory incidents, report preparation and CAPA establishment., Review of all quality control documents., Initiation and closure of change controls and incidents., Preparation, review of URS and initiation of change controls., Execution and approvals of validation documents (Installation Qualification, Operational Qualification and Performance Qualification of new Analytical instruments and Equipment's through an approved change control)., Preparation, review of standard operating procedures for new equipment's as well as revision of scheduled SOP's through an approved change control., 21 CFR Part 11 assessment for Software., Preparation of GxP assessment document., Trainings conducted to the end users before effective of the SOP., Verification of audit trails in standalone systems.

PSPO-1 Certified.

LabWare-8 Admin-1 Certified