SUMMARY:

• Technical Expertise - Technically astute and results-focused management professional with proven success in leadership roles in analysis of business requirements to design, support, and lead IT projects for strategic system solutions in a regulated pharmaceutical, healthcare, or biotech environment. Lifelong learner adept in ability to learn advanced technology and new concepts quickly to maximize organizational success.
• Customized Applications - Lead development of application software, management of CRM, ERP systems, production planning, manufacturing, material management, system analysis, resource tracking, and delivery of high-quality custom business applications.
• Regulatory Compliance - Ensure compliance with multiple regulated systems in biopharmaceutical companies requiring adherence to FDA, SOX, GXP, CS, 21 CFR part 11, SOP and other state and federal regulations.
• Staff Leadership & Collaboration - Skilled communicator with strong interpersonal abilities to develop rapport with internal and external customers, business and technical users, and management to provide report documentation and convey complex information in understandable terms.
• Pharmaceutical experiences
• Stem cell bank background
• Clinical product studies background
• Chemical Inventory Management
• ERP, CRM, LAB systems
• Aero Space repair & overhaul
• Asset/Risk Management
• Analytical & Quantitative Skills
• IT background
• Software Development Life Cycle (SDLC)
• Scrum
• Agile
• Waterfall methodology & etc.

TECHNICAL SKILLS:

Software & Languages: Microsoft 365, Jira, Perl, Unix Shell scripting, Microsoft Excel VBA, VB, PB, C#, XML, C, C++, SQL, HTML, Microsoft Visual Studio .NET, Business Objects, Crystal Reports, PL SQL, Oracle forms and Reports, J developer, Developer 2000, Pro*C, Java, J2EE, EL-program, Solution series S7 2.5/3.0, SalesLogix, StemLab, Solomon, Siebel CRM, ChemCart, LIMS, SAS and PC SAS, iOffice, Insight, Big Data tools and software, FTP & SFTP.

Databases: SYBASE, ORACLE, SQL SERVER, MS Access, Mango, Apache Hive.

CRM & ERP Tools: Veeva Salesforce, Saleslogix, Sibel CRM, Oracle, Impresa, Just In Time-JIT

Data warehouse Tools: Oracle warehouse builder, Oracle Designer and Informatica.

Case Tools: Oracle Discoverer, Erwin.

Other Tools: SQL*PLUS, Share Point, Sub Version. SQL Navigator, Change control, Release management, Quality Control, ITIL, Service Now & Help desk

Operating Systems: Windows, UNIX, LINUX, SOLARIS

Management Tools: MS Office 365, MS Project, MS Visio, PowerPoint

PROFESSIONAL EXPERIENCE:

Confidential, New Jersey

Freelancer/Contractor

Responsibilities:

• Upgrade ECCE/ SAS M7/ Pace/ Jira/QMS/AWS/Azure/GCP/Cloud storage/AI/IoT: Upgrade and delivered ECCE 1.2, SAS M7, Pace 4.1.2 and Jira platform in - house build software. Project management activity & tasks. MS office 365, Service Now, DocuSign, Jira, Varonis. Proficiency skills are Quality analysis, Applications, infrastructure, data science, data integrity, continuous improvement process (Agile, Scrums, DevOps & waterfall), Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management.

Confidential, New Jersey

Freelancer/Contractor

Responsibilities:

• Documentation Management System: Plan, design, requirements, validate, test cases, integrate, deploy the documentation management system for multiple applications.

Technology: Cloud storage, AWS, Azure, IoT, Data science, Analytics, AI, Automation. Methodologies: waterfall, Agile, Scrums, DevOps. Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management.

Confidential, Greater New York City Area

Freelancer/Contractor

Responsibilities:

• Provide IT solutions to the HR department from hiring till retirement process, which involves design, planning, requirements, develop, configure, test, implementation, deliver onboarding to retirement stages for the HR systems/ technology. Enhance/maintain data quality in the Oracle HCM and Service Now HR module. Work closely with HR and other depts and teams for business requirements. Tracked project tasks and deliverables using Microsoft Project management tool and delivered multiple reports like Gantt.
• Facility Ticket Tracking Management System: Plan, design, requirements, validate, test cases, integrate, deploy the iOffice application for multiple locations (USA and UK). Integrated with Service Now using API interfaces.

Technology: Cloud storage, AWS, Azure, IoT, Data science, Analytics, AI, Automation. Methodologies: waterfall, Agile, Scrums, DevOps. Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management.

Confidential, Summit, NJ

Responsibilities:

• Development / Data Analytic: Design, Develop & customized pharma applications to custom needed to support the Pharma business team like medical affair, Drug safety, Customer Service, Facility, HR and other department. Migrate data from legacy systems into middleware and upgrade applications. Databases and applications migrations, analysis data between applications, databases and file systems/servers.
• Veeva/Salesforce Migration: The SalesLogix CRM was migrated to the Salesforce CRM includes database, forms, reports and interfaces. The migration initiative was handled with vendor, offshore and onsite teams for the Confidential LifebankUSA / LifebankUSA.com.
• Website Deployment: Spearheaded LifebankUSA website and integration projects that required website hosting with an outside vendor, monitoring project control for business team, oversight of integration and implementation of SalesLogix, StemLab, Solomon, and website site deployment.

Technology: Unix, Pearl scripts, C++, Java, J2EE, PHP, Oracle, SQL, PL/SQL, Forms, Reports, Pro*C, SQL Loader, Oracle Database, Matrix, Blueprint, IRise, ServiceNow, ITSM reporting, IDMP, MODA, HP ALM, Concerto, DTP, Subversion, Manager, AWS/Cloud, Veeva, Salesforce, SAS, JIRA, Jreview, Manager, Review-please, InForm, Central Designer & Coding, Medidata RAVE, IRT, RBM, PACE, Pinnacle 21, QMS, EQMS, LIMS, CTMS/Clinical Product Study, SIEBEL, Facilities/Chemical Tracking System, CRM, ERP, LAB systems, Clinical DW/OBIEE, SharePoint, Publishing Systems, QMS Track-wise, CTD, eCTD, Parexel, Nees, Clinical and Safety Data ware systems, OBIEE, Bigdata & etc.

Confidential, Cedar Knolls, NJ

Freelancer/Contractor/FTE

Responsibilities:

• Website Management: Developed, design, updates, and support of company website. Collaborated with multiple departments to upgrade site and integrate other applications to optimize efficiency.
• IT Systems: Effectively led IT systems administration and support at the facility.
• Compliance: Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements.

Technology: Java, J2EE Cutting Edge Technology, Hibernate, Springs, Struts, Servlets, XML, PHP, VB, VB scripts, SalesLogix Solomon, StemLab, IDMP and LIMS. Oracle, SQL, PL/SQL, Forms, Reports, Pro*C, SQL Loader, Oracle Database, Oracle Designer, UNIX, LINUX & Pearl scripts, C++, SFTP & FTP

Confidential, Summit, NJ

IT Consultant

Responsibilities:

• IT Projects: Managed design and implementation of an order management system (COMS OP), reports system (CRS), integration of finance business codes in the C4 system, plus software source control system, and Req-Pro systems.
• Project Support: Provided technical support for all systems and applications and collaborated with multiple departments, the Sharp distribution vendor, and the Solomon customer care center. Track project tasks and multiple roles and responsible using MS project tool as a project deliverable.
• Compliance: Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements for the biopharmaceutical industries. Managed documentation and validation of documents.

Technology: Java, J2EE Cutting Edge Technology, XML, Oracle, SQL, PL/SQL, Forms, Reports, SQL Loader, Oracle Database, FTP & SFTP.

Confidential, Everett, WA

Senior Lead

Responsibilities:

• Worked on a multi-group team Developing customizing and maintaining Oracle Applications 10.7, Impresa 7.0, Company Portal, Ikon documents scanning process and Auto time (Kaba).
• Extensively developed customized and maintained Oracle application 10.7 for ATS (Aviation Technical services) for multiple modules like Inventory, purchasing, Finance, LTS (Labor tracking system) and customized Order entry.
• Involved in implementation, customization and maintenance of IMPRESA, an enterprise-wide application for multi-location MRO (maintenance, repair, and overhaul) in many components divisions of Goodrich across the nation. Developed and maintained multiple customized modules like Deferred Assets, work order status, Inventory, purchase, finance and multi-plant process.
• Customer support, development and maintenance across ATS for Company Portal using Microsoft ASP .NET and maintain IKON documents process.
• Involved in Auto-time web report development using Microsoft ASP .Net and building PL/SQL packages to retrieve the data from database using ref-cursor.
• Developed PL/SQL packages extensively to migrate data from various legacy applications to Oracle and during migration of Impresa to Oracle Applications and also customized forms and reports.
• Involved and established coding standards and guidelines.
• Automated ATS Calibration tools pickup process.
• Automated Alternate item master process.
• Followed FAA regulation required in Aerospace industry and involved in documenting validation documents.
• Extensively tuned the Impresa application and redesigned the queries in forms and reports to perform well without affecting the functionality and setting up or changing the report parameters for an effective performance.
• Worked with other team members on tuning several applications especially on SQL tuning using trace, and TKPROF utilities.

Environment: Oracle 9i, 8i, 7.3.4, MS SQL Server 2000/7.0, HP-UX 10.20, Sun Solaris, DYNIX, Oracle Applications 10.7/11i, Impresa 7.0, Erwin, Developer 2000, PL/SQL

Confidential

Senior Programmer Analyst Shreveport

Responsibilities:

• Designing the relational database table structures
• Analysis the Focus segment file structure
• Scripts for building tables and error handling
• Loading data using SQL*Loader

Environment: Oracle 7.3, HP-UX, PL/SQL, SQL*Loader

Confidential

Software Engineer

Responsibilities:

• Involved in testing, debugging, installing Solution/Series software and maintaining quality process.
• Involved in taking care of solution for the Year 2000 problem through Solution/Series v.3.0 and Conversion from Solution Series v2.5 to v3.0.
• Developed reports for Payroll Schedule process and Human Resource Process.

Environment: Windows 95 and DOS on Pentium based PC’s using EL-Program and Solution Series S7 - 2.5/3.0.

Confidential, MN

Software Engineer

Responsibilities:

• Involved in the design of HLD, LLD, of Structural Maintenance Module (SM).
• Coding, debugging & testing of purchase order and RO (Repair and Overhaul) module.
• Created reports for purchase orders printing process and RO Modules.

Environment: Solaris v.2.3, Windows 95 on SUN SPARC Workstation using Oracle v.7.x as back end and Developer 2000 as the client

Confidential

Software Engineer

Responsibilities:

• Design and develop custom build reports.
• Tuning queries
• Prepared Unit Test Plans

Environment: SUN SPARC Workstation v.20 on Solaris v.2.3 and Windows NT using Oracle v.7.3 and Developer 2000.

Confidential

Software Engineer

Responsibilities:

• Involved in analysis, design, and testing of the above modules.

Environment: Oracle v.7.3 as back-end with Designer-2000 as front-end.