Involve in case distribution activities
• Communicate with colleagues regarding resolution of safety concerns and queries
• Perform data entry for all types of reports including Clinical trial, Spontaneous, Study cases using ARISg and LSMV database.
• Processing of SUSAR, malfunction reports and blinding techniques.
• Processing of Pregnancy
Involve in case distribution activities
• Communicate with colleagues regarding resolution of safety concerns and queries
• Perform data entry for all types of reports including Clinical trial, Spontaneous, Study cases using ARISg and LSMV database.
• Processing of SUSAR, malfunction reports and blinding techniques.
• Processing of Pregnancy reports in accordance with updated SOP and user manuals.
• Execute clear and accurate data capture of ICSRs and appropriate medical assessment of ICSRs in accordance with regulatory guidelines/client conventions and SOPs
• Involve in case book in and follow up process activities. Critical customer Call channels and downstream integrations (SIT) validation support
• Maintain knowledge of global health authority regulations and requirements.
• Responsible for case intake, duplicate check and registration in Argus safety database.
• Communicating with colleagues regarding resolution of safety concerns and queries.
• Executes clear and accurate data capture of case safety reports and doing appropriate medical assessment in accordance with regulatory guidelines/client conventions and SOPs.
Managed end-to-end financial planning, budgeting, and forecasting to align with business
objectives.
- Conducted in-depth cash flow analysis and financial reconciliations to optimize liquidity and
operational efficiency.
- Led financial statement analysis, trend identification, and cost reduction strategies to enhance
financial performance.
- E
Managed end-to-end financial planning, budgeting, and forecasting to align with business
objectives.
- Conducted in-depth cash flow analysis and financial reconciliations to optimize liquidity and
operational efficiency.
- Led financial statement analysis, trend identification, and cost reduction strategies to enhance
financial performance.
- Ensured compliance with GAAP and financial reporting standards by implementing best
practices and conducting rigorous financial reviews.
- Managed tax filings, statutory audits, and financial regulatory compliance for businesses and
individuals.
- Led internal and statutory audits, ensuring full compliance with regulatory standards and
financial reporting requirements.
Ensuring that works are delivered on time, meet business & technical requirements and are within the agreed budget.
• Anticipate, manage and resolve issues and act as the point of contact for the domain build-run team.
• Performance reviews with direct reports.
• Managing stakeholders from all levels
• Setting up of value streams working clos
Ensuring that works are delivered on time, meet business & technical requirements and are within the agreed budget.
• Anticipate, manage and resolve issues and act as the point of contact for the domain build-run team.
• Performance reviews with direct reports.
• Managing stakeholders from all levels
• Setting up of value streams working closely with business stakeholders/IT Practise head.
• Coordinate with client and handle all expectations related to resourcing, process following, quality, SLA’s and KPI’s
• Generate monthly reports and present them to stakeholders.
• Coaching and mentoring” Customized Career Development Plans” and “ Training Plans” for team Members.
• To recruit, train, organize, lead and motivate the staff.Monitor and supervise the performance of reporting staff; delegating responsibilities, scheduling, coaching and correcting, evaluating, interviewing, training and mentoring of staff.
• Maintain track of revenue, cost , EBIDTA, Gain Margin, KPI’s and SLA on a monthly basis.
• Collaborated closely with stakeholders to analyse & evaluate Business requirements for design provisioning and approve workflows.
Supporting 3000 instances which includes 1000 production instances
• Upgrade/Migration of Databases from different Oracle versions.
• Upgrade / Migration from Windows to Unix servers
• 19c Data Guard setup in Windows and Unix servers
• OEM agent installation for monitoring the DB
• OEM Agent upgrade from 13.4 to 13.5 in DB servers
• Used TOAD f
Supporting 3000 instances which includes 1000 production instances
• Upgrade/Migration of Databases from different Oracle versions.
• Upgrade / Migration from Windows to Unix servers
• 19c Data Guard setup in Windows and Unix servers
• OEM agent installation for monitoring the DB
• OEM Agent upgrade from 13.4 to 13.5 in DB servers
• Used TOAD for database management.
• Performed SQL and PL/SQL tuning, oracle contention and monitored production database using automatic workload repository (AWR), automatic database diagnostic monitor (ADDM) and Active Session History (ASH).
• Performed Database Maintenance Tasks, Rebuilding Fragmented tables, gathering statistics, refreshing materialized views, created partition tables and maintaining indexes
• Enabled Flashback for database to create restore points and supporting DDL changes
• Login for the Keystore for cdb$root and Pluggable databases
• Applied PSU quarterly on 11g/12c/19c GRID & RDBMS homes using opatch auto and Up-gradation of 11g/12c/19c databases and Implementing catalog backup from RMAN
Physical inspection to identify electrical hazards like shock, fire, explosion, overloading and to suggest electrical safety solutions, plant lightning protection system, static electricity hazards in the plant operations.
• Review of hazardous area classification and selection of flameproof electrical equipment in the plant, including mai
Physical inspection to identify electrical hazards like shock, fire, explosion, overloading and to suggest electrical safety solutions, plant lightning protection system, static electricity hazards in the plant operations.
• Review of hazardous area classification and selection of flameproof electrical equipment in the plant, including maintenance aspects.
• Review of electrical preventive maintenance system including tests, documentation, history cards.
• Review of electrical accidents and near misses in the plant to identify the root causes.
• Review of electrical systems & procedures like work permits, interlocks, lockout tags.
• Review of the importance given to electrical safety in the company safety policy, safety committee, continuous electrical risk identification.
• Assessing the integrity of insulation of cables by carrying out insulation resistance tests on a sample basis.
• Review of the earthling system (installation & maintenance aspects), including sample earth resistance tests
• To identify areas of overloading by carrying out load current measurements and compared against cable current carrying capacity calculation
• Ensuring Public health & Environment.
Responsible for managing a team of BAs and driving IT RFXs across multiple verticals (BFSI, Utilities, Communications & Media, CPG, Government & Public Sector) in regions such as the US, EU, AMEA, and ANZ, with end-to-end ownership of drafting proposal responses for various areas, including Cloud Migration, Digital Transformation, Pega Up
Responsible for managing a team of BAs and driving IT RFXs across multiple verticals (BFSI, Utilities, Communications & Media, CPG, Government & Public Sector) in regions such as the US, EU, AMEA, and ANZ, with end-to-end ownership of drafting proposal responses for various areas, including Cloud Migration, Digital Transformation, Pega Upgrades, Application Development, Application Support and Maintenance, and Business Consulting.
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Experience in managing small to medium deals ranging from 1+ mil USD to 20 mil USD
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Single point of contact for small to medium deals and driving them to closure. Acted as offshore lead for large transformational and outsourcing deals worth more than 10+ million USD
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Has exposure and experience in responding to Pega proposals for call center transformation, upgrades to Pega Infinity, Onboarding, KYC, Credit risk Decisioning, Collections, Smart Disputes and customer DD solutions
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Joint GTM activities with Pegasystems & Business development activities
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Collaborate with the BU leads/ COE teams/ Solution leads/Delivery Managers to develop proposals/RFI responses that lead to winning new Accounts.
Conducted thorough business analysis and suggested application improvements, developing and executing a product roadmap that resulted in a 20% increase in user engagement and 15% revenue growth.
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Effectively communicated with stakeholders, customers, and users, performing detailed requirements gathering and business analysis to identify ga
Conducted thorough business analysis and suggested application improvements, developing and executing a product roadmap that resulted in a 20% increase in user engagement and 15% revenue growth.
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Effectively communicated with stakeholders, customers, and users, performing detailed requirements gathering and business analysis to identify gaps and enhance user experience by 30%, scale application efficiency by 25%, and reduce errors by 20%. This increased overall project success and user satisfaction.
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Led cross-functional teams to deliver new features on time and within budget, achieving a 98% success rate in product releases.
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Created comprehensive documentation, including BRDs, MOMs, features, epics, stories, design documents for functional flow, test plans, release notes, and application guides.
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Prioritized product backlog items and defined user stories to align with business objectives and enhance user experience by 30%.
Led end-to-end SDLC for enterprise-level Angular and React applications, ensuring high performance and scalability
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Architected AWS-powered contact center solutions, integrating AWS Lambda, Amazon Connect, and Genesys Softphone
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Managed cross-functional teams, mentored junior engineers, conducted code reviews, and enforced best practices
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Co
Led end-to-end SDLC for enterprise-level Angular and React applications, ensuring high performance and scalability
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Architected AWS-powered contact center solutions, integrating AWS Lambda, Amazon Connect, and Genesys Softphone
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Managed cross-functional teams, mentored junior engineers, conducted code reviews, and enforced best practices
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Collaborated with vendors and stakeholders, aligning engineering efforts with business objectives.
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Spearheaded Angular migration projects (v9 to v11) and optimized UI components for responsiveness and accessibility.
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Designed and developed front-end architectures for global clients like PayPal, eBay, Aetna, Walgreens
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Led teams in building React.js, Angular, and Knockout.js applications with a strong focus on performance
Lead person to review the planning of Assembly and Child parts production as per the customer order.
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Responsible person to provide commitments of dispatch targets to customers and ensure the dispatch to be done as per committed target.
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Lead person to review the daily based status provided by functional managers on the activities planned a
Lead person to review the planning of Assembly and Child parts production as per the customer order.
•
Responsible person to provide commitments of dispatch targets to customers and ensure the dispatch to be done as per committed target.
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Lead person to review the daily based status provided by functional managers on the activities planned against sale orders.
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Lead person to monitor regular departmental activities such as periodic maintenance of machines, monthly Inventory report and Production reports.
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Responsible person to provide training to Production supervisors & Operators and motivate the people working in the Shopfloor to achieve targets.
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Responsible person to understand the issues with operators and find ways to make the working place better for people working on the shop floor.
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Responsible person for analyzing existing processes & alleviating loopholes to execute relevant measures for minimizing scrap or rejections.
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Periodic review on the production performance with help of control charts, identifying major problems and analysing & controlling the problems with help of Problem-solving methodology such as DMAIC and 8D.
Managing and guiding a group of Scientists expertise in Handling of various formulations for Analytical method developments, Analytical Method Validations, Analytical Method Transfers and stability studies.
Responsible for the Completion of allotted Projects within timelines and meeting milestones. Other responsibilities like review of A
Managing and guiding a group of Scientists expertise in Handling of various formulations for Analytical method developments, Analytical Method Validations, Analytical Method Transfers and stability studies.
Responsible for the Completion of allotted Projects within timelines and meeting milestones. Other responsibilities like review of Analytical method development reports, method validation protocols and reports, method transfer protocols and reports, other analytical documents related to method equivalency studies, regulatory query responses etc.,
Preparation of timelines for new projects and responsibility allocation to the team for completing the projects within the timelines.
Planning and monitoring of analytical method development, analytical method validation activities and analysis of samples of proto-type development samples and stability samples.
Monitoring the planning and coordinating the team subordinates for smooth function of all activities and providing guidance to the team for trouble shooting. Management of work plan and utilization of resources efficiently.
Handling different customers via teleconferences or mail communications. Updating them progress related to projects, evaluating their requirements and meeting them as per regulatory guidances.
As a statistical programmer within the Neurosciences Therapeutic area, involves in
development and validation SDTM datasets, including safety ADaM datasets, ensuring
compliance with CDISC standards by using tools like Pinnacle 21 and Novartis procedural
processes.
• Create and validate analysis datasets (ADaM) as per Statistical Analysis Plan
As a statistical programmer within the Neurosciences Therapeutic area, involves in
development and validation SDTM datasets, including safety ADaM datasets, ensuring
compliance with CDISC standards by using tools like Pinnacle 21 and Novartis procedural
processes.
• Create and validate analysis datasets (ADaM) as per Statistical Analysis Plans (SAPs) and
mock shells.
• Program and validate TFLs (Tables, Figures, Listings) in accordance with SAPs and mock
shells, ensuring accurate representation of clinical trial data.
• Stay abreast of the latest industry and CDISC standards, as well as ICH and USFDA, other
regulatory guidance and requirements
• As a Junior statistical analyst within the Oncology Therapeutic area, involved in
development and validation of SDTM datasets
Directed and implementation Quality assurance & quality control processes, Quality Assurance audit program & Quality Management Systems in Clinical Research (Phase I to IV) and BA/BE CRO.
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Specifically includes BA/BE study facility, Central clinical laboratory, biometrics, Clinical Data Science, Pharmacovigilance and computerized clinical
Directed and implementation Quality assurance & quality control processes, Quality Assurance audit program & Quality Management Systems in Clinical Research (Phase I to IV) and BA/BE CRO.
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Specifically includes BA/BE study facility, Central clinical laboratory, biometrics, Clinical Data Science, Pharmacovigilance and computerized clinical Systems as per as per GCP/GLP/GCLP, 21 CFR part 11 and the relevant regulatory standards.
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Review and approval of QMS (Quality manual, Quality Agreement, Deviations, Change Control, CAPA, incidences, investigations etc.) - Coordinated with cross-functional teams to develop standard operating procedures (SOPs) for all functional areas that met or exceeded all regulatory standards, minimizing the risk of non-compliance fines.
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Successful implementation of quality, ethics and scientific conduct and performed regulatory compliance audits of more than 200 Investigator site audits, more than 150 BA/BE and PK patients studies audits and more than 05 therapeutic equivalence/efficacy drug phase II and III trials as a lead auditor.
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Successful conduct more than 100 BA/BE, 50 Phase- III studies monitoring to ensure that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for ICH GCP.
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Developing global auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc.,
Process documents preparation work(FMEA,SOP,TDS,WSS,CR & FSS)
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Process cost reduction work(cycle time, setup time & tool cost)
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CNC machines troubleshooting activity’s(HMC,VMC,HTL&SPM)
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Fanuc Robots (4&6 Axis) handling and troubleshooting work
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Capacity planning based on customer demand
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Planning work through Systematic approach.
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Coordinate wi
Process documents preparation work(FMEA,SOP,TDS,WSS,CR & FSS)
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Process cost reduction work(cycle time, setup time & tool cost)
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CNC machines troubleshooting activity’s(HMC,VMC,HTL&SPM)
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Fanuc Robots (4&6 Axis) handling and troubleshooting work
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Capacity planning based on customer demand
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Planning work through Systematic approach.
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Coordinate with cross function team
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Layout planning and preparation
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Setup sheet preparation.
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Process documents preparation work(FMEA,SOP,TDS,WSS,CR & FSS)
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Process cost reduction work(cycle time, setup time & tool cost)
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CNC machines troubleshooting activity’s(HMC,VMC,HTL&SPM)
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Fanuc Robots (4&6 Axis) handling and troubleshooting work
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Capacity planning based on customer demand
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Planning work through Systematic approach
Prepare and presenting weekly maintenance review meeting with top management.
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Permanent root case action against breakdowns.
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Root cause and analysis reducing MTTR and increasing MTBF.
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Machine breakdowns like, Electrical, Electronics, Mechanical, Pneumatic, Hydraulics breakdowns.
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Responsible for all machine breakdown and preventive and pre
Prepare and presenting weekly maintenance review meeting with top management.
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Permanent root case action against breakdowns.
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Root cause and analysis reducing MTTR and increasing MTBF.
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Machine breakdowns like, Electrical, Electronics, Mechanical, Pneumatic, Hydraulics breakdowns.
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Responsible for all machine breakdown and preventive and predictive maintenance.
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Man power planning for breakdown and plant maintenance team.
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PLC &HMI and analog module programming.
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Preparing PM scheduling & executing the carry over job.
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PLC and Contactor logic machine rewiring activity.
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Industrial 4.0 activities like OEE, traceability, Scada projects.
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All kind of machine calibration maintaining like torque sensor, load cell and nut runners.
Cradle to Grave” responsibility of the entire Topside and subsea pipeline Valve package, Line pipes, fittings and Barred Tee through the full life cycle of the project.
Valve packages handled involves high pressure topside and Subsea Actuated and Manual Ball (API 6A & 6D), gate, globe, check, Plug, DBB and automated choke valves with ove
Cradle to Grave” responsibility of the entire Topside and subsea pipeline Valve package, Line pipes, fittings and Barred Tee through the full life cycle of the project.
Valve packages handled involves high pressure topside and Subsea Actuated and Manual Ball (API 6A & 6D), gate, globe, check, Plug, DBB and automated choke valves with overall 80 Million worth PO values.
Focal point for McDermott / Client and Vendors
Tender support and review of vendor valve proposals
Review the P.O under commercial impacts.
Co-ordinate all vendor document IDC review and distribution (through the document review matrix, Engineering, QA/QC, Mechanical completion, Project schedule). Responsible for final approval of all documents.
Lead Meetings with vendor, McDermott and Company for package execution.
Arrange P.O kick off meetings and PIM meetings.
Resolve all technical and physical issues until final commissioning is completed.
Witness FAT of critical valves at vendors works and expedite the delivery of valves
Responsible for the reliability of valves integrity in McDermott Yard prior to installation.
Oversee a credit portfolio of INR 14,500 Mn, managing Working Capital, Trade Finance, Term Lending, and Project Funding.
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Exercise sanctioning authority up to INR 100 Mn (new) and INR 300 Mn (existing) with 100% compliance to corporate credit policies.
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Conduct credit rating assessments based on financial, business, industry, and management
Oversee a credit portfolio of INR 14,500 Mn, managing Working Capital, Trade Finance, Term Lending, and Project Funding.
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Exercise sanctioning authority up to INR 100 Mn (new) and INR 300 Mn (existing) with 100% compliance to corporate credit policies.
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Conduct credit rating assessments based on financial, business, industry, and management risk evaluations.
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Maintain a high-quality credit portfolio with zero slippages and delinquency.
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Established team priorities, maintained schedules and monitored performance.
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Implemented effective training programs to enhance employee skills and improve overall job satisfaction.
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Increased revenue generation by identifying new business opportunities and expanding existing client relationships.
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Optimized resource allocation ensuring efficient use of personnel in achieving objectives.
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Collaborated with cross-functional teams to optimize workflow processes, increasing overall productivity rates.
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