Vivek V Subbaraju Bh

Inspection readiness

• Handling Regulatory audits , corporate audits and local audits, Developed backroom , front room team to facilitate inspections.
• Perform Regulatory Observations Network Assessments (RONA) to identify gaps at site and implement CAPAs within agreed timelines.
• Co-ordinate with Pfizer global Inspection Readiness and global Subject Matter Experts for Inspection Readiness activities.
• Presentation of Site Inspection Readiness to Site leadership and above site leadership meetings (IR Limited).
• Quality Culture Maturity Assessment (QCMA) and timely update of Quality Improvement Plan (QIP).

QTS/eQMS Management

• Liaise with Digital and global teams for new modules/ platforms deployment and enhancement /upgrades in gQTS/ eQMS systems.
• Represent as Subject Matter Expert for gQTS/eQMS and management of end users and access roles.
• Support to resolve day-to-day queries and take-up system enhancements to global team to fix issues.

Site Quality Metrics:

• Responsible for management of Site Quality Review program at site.
• Implement Quality/ Site objectives - identify key performance indicators through which Quality /Site of objectives can be measured.
• Liaise with internal and external stakeholders who understand process in defining metrics and their targets.
• Develop strategy for improved compliance against metrics and maintain systems to measure performance against established targets.
• Analyze large data sets, draw valid inferences, and present them to Management by developing effective visual dashboards that present data that is as close to real-time as possible to support decision process of continual improvement activities.
• Facilitate Site Quality Review meeting and ensure all key metric presented to management & actions indicated are addressed and successfully implemented.

• Site Deployment owner and SME for Pfizer Electronic logbook management system.
• Co-ordination with IT, Business owner, Validation, Quality, Site lead for Deployment plan approval.
• Developed Project charter - Identifying Scope of project and Business sponsor approvals & deployment.
• Risk assessment, Change control , impact assessment, Preapproval of implementation of Electronic system.
• Validation Strategy, testing of Electronic record and Electronic signatures, and Validation Completion.
• Testing of application in application life cycle management in staging and approval of system per user requirements.
• Development of procedures, training materials and instruction lead trainings for all site user approx. 1500 colleagues.
• Site support & hyper care to resolve the reported issues.
• Identify complex Procedures/ Processes Simplify and Make it easier to get things done at site.
• Phase wise project completion utilizing PDCA approach.
• Implementation of PHP tools during procedure and forms preparation for ease of execution.
• Trained on Method 1/DMAIC for investigations.

Risk assessment, Change control and Corrective actions & Preventive actions:

• Preparation, reviews Quality Risk Assessments for equipment, process.
• Initiation of mitigation action items to implement controls, tracking and closing of action item using global quality tracking system.
• Subject matter expert on Gowning, Non-viable particular count, Online particle measuring system.
• Driving process and system improvements in Operations to facilitate improvements through QMS (Quality management system).

Consumable Specifications:

• Review of consumable’s materials procured and review of specification documents in electronic systems.

Trending activity:

• Review of NVPC trends based on procedure frequency (Monthly, Half yearly, annually).
• Data review & system reports review to ensure compliance.

• Supervise the component preparation areas of aseptic manufacturing.
• Expert on Autoclave (steam sterilizer) and Vaporized hydrogen peroxide decontamination transfer chamber (VHP) with THEMA4 systems.
• Identified as key player and was sent to Hospira US site McPherson.
• Factory acceptance test, site acceptance test, IOPQ for process equipments.
• Execution of Site acceptance test, Installation qualification, operation qualification of equipments.
• Cycle development and performance qualification of equipments and area qualification.