Bengaluru, Karnataka, India
Experienced professional with wide range of experience across Quality aspects of a Pharmaceutical industry. Experience includes Analytical Method validation, Computerized system validation, Program Management, People Management, Regulatory Affairs and Quality Assurance.
Hands on experience in quality management Systems and manpower supervision in Quality control. Implemented the highly successful Lean Training and Six Sigma projects. Effective cross functional team co-ordination for streamlining the product delivery on time. Significant understanding of all aspects of governing, operational, and Quality Control activities and up-to-date knowledge of latest technological advancements, regulations/ guidelines, & statutory compliances in the industry. Technical evaluation and In-depth assessment of the requirements of each cross functional team for delivering the projects on time. Responsible for Risk assessment as a part of the project initiation and Risk mitigation based on the project deliverables. Gantt chart preparation for planning and prioritization of each minute segment of the project. Handling of Change Control and Deviations effectively based on the requirement of the project. Man-power management in coordination with Human resource team. CAPEX execution in co-ordination with cross functional teams to deliver the required resources for the smooth execution of the project. I am involved in Vendor management for supply and release of raw materials. Was involved in vendor evaluation Audit across various companies in China in 2017. Was responsible for Knowledge transfer on Analytical techniques involved in Testing and approval of the products to a company in Hungary in 2018.
Was majorly into Audit trail review of the Batch analysis reports. Was in charge of Preparation and execution of protocols and reports related to Analytical instrument and software qualification of the application software being used at Quality control. Was actively responsible for Preparation of Master Validation plan for Application software used in the department. Excel spread sheets validation used in the calculation and reporting of the results pertaining to qualitative analysis, calibration, Linearity etc.
Was Performing System audit trails for instrument with CDS and stand-alone instruments. Review of analytical Reports related to in-process, finished product, stability samples and Method Validations. Was responsible for Preparation of Calibration planner and Standard qualification planner.
Sole In charge of Allotment of testing samples to the entire ream and reporting of results. Vendor management by communicating and placing orders for chemicals, columns, instruments and other requirements cost effectively. Responsible for training the team to meet market standards.
Responsible for Sampling of raw materials (tankers, poly bags, PVC containers) and Finished Products Responsible for Preparing and performing Method Validation. In charge completely for Calibration of Analytical Instruments and preparations of Specifications.