VENKATSAI BASA

• Spearheaded the planning and execution of IT infrastructure for the establishment of a new injectable plant, ensuring alignment with regulatory requirements and business objectives.
• Developed and implemented User Requirement Specifications (URS) for IT systems, encompassing equipment and software to meet pharmaceutical manufacturing needs.
• Established and managed Standard Operating Procedures (SOPs) governing IT processes to maintain compliance with GxP guidelines, 21 CFR Part 11, and industry best practices.
• Managed validation efforts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of IT systems.
• Network Architecture and Design: Spearheaded the implementation of network architecture and design enhancements, ensuring seamless connectivity and optimized performance across departments.
• Standard Operating Procedures (SOPs): Implemented SOPs for routine IT activities, ensuring standardized practices and operational efficiency.
• Centralized Virtual Machine Infrastructure: Led the deployment of a centralized virtual machine infrastructure for QC, MB, QA, R&D, Production, and Engineering servers, optimizing resource allocation and accessibility within budget constraints.
• Centralized Document Server: Implemented a centralized document server integrated with the domain controller, facilitating efficient collaboration and document management across manufacturing and R&D departments.
• Vendor Coordination: Coordinated with vendors for IQ OQ PQ processes for all related implementations, ensuring compliance with company and regulatory requirements.
• Budgetary Compliance: Ensured that every solution was linked with the economic budget, optimizing costs without compromising quality.
• Backup Network Storage Device: Implemented a backup network storage device using Synology NAS storage for servers and clients, ensuring reliable data protection and disaster recovery capabilities.
• Sophos Firewall Implementation: Deployed Sophos firewall solutions based on plant and R&D requirements, configuring switches and implementing CCAMERAS NVR across the entire facility to enhance security and surveillance capabilities.
• Email Server Maintenance: Managed email server maintenance and policy creation as per SOPs, ensuring secure and efficient communication channels.
• LabSolution Application for R&D and QC:
• Implementation and Integration:
• System Maintenance:
• Data Management:
• Chromeleon Application for R&D and QC :
• Installation and Configuration
• Maintenance and Support
• Implemented robust IT security measures, including access controls, audit trails, and electronic signatures, to ensure compliance with industry standards.
• Conducted risk assessments, vulnerability assessments, and security audits to protect sensitive pharmaceutical data and maintain regulatory compliance.
• Maintained an up-to-date library of SOPs for IT processes, providing clear guidance for staff and supporting documentation compliance.
• Collaborated closely with Quality Assurance and Regulatory Affairs teams to ensure that IT systems met FDA and other regulatory agency requirements.
• Stayed current with emerging technologies and recommended IT solutions to improve efficiency and compliance, supporting the overall success of the new plant project.

Led the planning and execution of IT infrastructure for the establishment of a new injectable plant, ensuring alignment with regulatory requirements and business objectives.

Developed and implemented User Requirement Specifications (URS) for IT systems, encompassing equipment and software to meet pharmaceutical manufacturing needs.

Established and managed Standard Operating Procedures (SOPs) governing IT processes to maintain compliance with GxP guidelines, 21 CFR Part 11, and industry best practices.

Managed validation efforts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of IT systems.

Implemented robust IT security measures, including access controls, audit trails, and electronic signatures, to ensure compliance with industry standards.

Conducted risk assessments, vulnerability assessments, and security audits to protect sensitive pharmaceutical data and maintain regulatory compliance.

Maintained an up-to-date library of SOPs for IT processes, providing clear guidance for staff and supporting documentation compliance.

Collaborated closely with Quality Assurance and Regulatory Affairs teams to ensure that IT systems met FDA and other regulatory agency requirements.

Stayed current with emerging technologies and recommended IT solutions to improve efficiency and compliance, supporting the overall success of the new plant project.

Managed IT infrastructure within the pharmaceutical plant, ensuring the performance of critical systems and regulatory compliance.

Developed User Requirement Specifications (URS) for new IT systems and equipment, aligning them with pharmaceutical manufacturing needs.

Ensured adherence to 21 CFR Part 11 regulations, including security controls and electronic signature implementations.

Conducted routine system maintenance, software updates, and validation activities for IT systems.

Collaborated with crossfunctional teams to address ITrelated issues and improve manufacturing processes.

Contributed to the training and development of employees, promoting IT procedures and compliance.

• Implemented staff training programs, enhancing product knowledge and improving customer service skills.
• Ensured compliance with all safety regulations by conducting regular inspections of equipment/operations within the store.
• Enforced company policies consistently while handling disciplinary actions when necessary with fairness and respect.
• Improved customer satisfaction by addressing and resolving complaints promptly.
• Facilitated clear communication between employees and upper management through regular meetings and updates.
• Developed strong working relationships with staff, fostering a positive work environment.
• Scheduled staff shifts to ensure proper coverage during peak shopping hours without exceeding labor budgets.
• Mentored junior staff members in their professional development by offering guidance/support in their assigned roles.
• Managed inventory levels to minimize stockouts while reducing overhead costs.
• Promoted teamwork within the workplace by encouraging collaboration among staff members on various projectstasks.
• Increased sales through effective merchandising strategies and targeted promotions.
• Coordinated with vendors to ensure timely delivery of products and resolve any supply chain issues.
• Collaborated with the management team to develop strategic plans for business growth and improvement.
• Maintained a clean, safe, and organized store environment to enhance the customer experience.
• Boosted employee morale by recognizing outstanding performance and celebrating team accomplishments.
• Assisted in recruiting, interviewing, hiring, and onboarding of new employees to maintain adequate staffing levels.
• Streamlined store operations for increased efficiency, implementing new processes and procedures.
• Conducted employee performance evaluations, providing constructive feedback for growth and development.
• Oversaw daily cash reconciliations, ensuring accurate financial reporting and minimizing discrepancies.
• Monitored sales trends to adjust pricing strategies accordingly for optimal profitability.
• Monitored cash intake and deposit records, increasing accuracy, and reducing discrepancies.
• Strengthened merchandising and promotional strategies to drive customer engagement and boost sales.
• Offered hands-on assistance to customers, assessing needs, and maintaining current knowledge of consumer preferences.
• Generated repeat business through exceptional customer service and responded to customer concerns with friendly and knowledgeable service.
• Completed regular inventory counts to verify stock levels, address discrepancies, and forecast future needs.
• Made hiring recommendations to increase company's productivity and profitability with quality workers.
• Helped with planning schedules and delegating assignments to meet coverage and service demands.
• Created employee schedules to align coverage with forecasted demands.
• Developed loyal and highly satisfied customer base through proactive management of team customer service strategies.
• Reviewed sales and gross profit report to assess company efficiency.
• Mentored team members to enhance professional development and accountability in workplace.
• Monitored security to protect employees, customers and property.
• Increased employee performance and job satisfaction to strengthen retention and engagement.
• Supervised day-to-day operations to meet performance, quality and service expectations.
• Developed strategy to increase sales and drive profits.
• Defined clear targets and objectives and communicated to other team members.
• Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
• Assisted in organizing and overseeing assignments to drive operational excellence.
• Identified and communicated customer needs to supply chain capacity and quality teams.
• Maintained professional demeanor by staying calm when addressing unhappy or angry customers.
• Developed detailed plans based on broad guidance and direction.
• Trained personnel in equipment maintenance and enforced participation in exercises focused on developing key skills.
• Controlled resources and assets for department activities to comply with industry standards and government regulations.
• Improved staffing during busy periods by creating employee schedules and monitoring call-outs.
• Launched quality assurance practices for each phase of development
• Opened and closed location and monitored shift changes to uphold successful operations strategies and maximize business success.
• Streamlined and monitored quality programs to alleviate overdue compliance activities.
• Managed senior-level personnel working in marketing and sales capacities.
• Established team priorities, maintained schedules and monitored performance.
• Established performance goals for employees and provided feedback on methods for reaching those milestones.
• Set aggressive targets for employees to drive company success and strengthen motivation.
• Evaluated employee performance and conveyed constructive feedback to improve skills.
• Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
• Planned, created, tested and deployed system life cycle methodology to produce high quality systems to meet and exceed customer expectations.
• Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
• Reduced waste and pursued revenue development strategies to keep department aligned with sales and profit targets.
• Used industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.
• Leveraged data and analytics to make informed decisions and drive business improvements.
• Successfully managed budgets and allocated resources to maximize productivity and profitability.