PROFESSIONAL SUMMARY

Sarala Penumatsa, Shrewsbury, MA 015**-***-*** 8986 ado2dy@r.postjobfree.com

Enthusiastic and committed Director IT and Operations at Manufacturing Industry. Operated in all facets of healthcare i.e., clinical development teams, strategic planning, product development, business analytics, forecasting and budgeting.

Summary of Skills

Overseeing technical projects in alignment with organizational goals

Experience in developing and driving data generation strategies in healthcare to achieve organizational goals.

Worked closely with clinicians, scientists, statisticians to build digital tools around clinical data

In-depth medical knowledge in health IT ecosystem

Domain experience in Supply Chain, Procurement, Finance

Participated in ISO, GMP, WHO and Customer audits

Worked closely with analytical laboratories to improve sampling process

Shared ideas with all stakeholders and gained their trust to build team

Supervised a team while working closely with executive team, external vendors, and partners

Bridged the gap between business and technology by working with information engineers by finding solutions to business activities

Hands-on in optimizing resources and ensuring effective program execution

Implemented strategies to generate reports to monitor daily progress and gain insight for future

Effective communicator and motivator who identifies and leverages

Establishing terms, pricing, quality requirement, delivery, and contracts

Proficient in revenue growth and business development

Familiarity in Benchtop laboratory equipment, R&D, Security, Quality, Safety

Work Experience

Hi-Tech Pharmaceuticals, Director IT and Operations June 2012-Present

Maintain project coordination between higher management and production team to meet manufacturing operations

Worked with lab engineers to develop tools that will minimize material process time in R&D, QA, QC, Microbiology which in turn improved production

Implemented document and data management system for Product Stability Studies, Lab, Inventory, Rejected materials.

Integrated Chromatography Data System, HPLC, HMI and robots to track and control wherever precise, repetitive tasks must be performed.

Streamlined Master BMR, Change Control Requests, Analytical Test Procedure with right processes in place

Build processes for reviewing and approving proposed CAPA, APR’s and PQR’s

Developed long term plan to deal with changing regulatory norms and technological trends by working closely with QA and QC teams

Played key role in moving few products to nanotechnology space

Actively managed project timelines and schedules achieving delivery of high-quality projects on time

Migrated manual production process to digital to meet GMP and WHO

Gathered and organized statistical information regarding time, cost, and efficiency

Predict and assess operational problems, risks, and solutions

As a part of agile continuously reviewed processes and improved as necessary to drive efficiencies throughout the provisioning lifecycle

Develop project plan timelines, identifying applicable phases, tasks, resources, and dates to drive all project schedules.

April 2009-2012

Agfa HealthCare, RI Principal Software Engineer

Played a key role in analysis, design and development of the Cardiovascular Reporting product which uses SNOMED Clinical Terms. Worked closely with hospitals and doctors to capture relevant information. Worked on Enterprise Imaging Platform which provides clinical confidence with patient-centric intelligence.

March 2002-2009

Pfizer, CT Tech lead

Worked in pharmacogenomics area, where my role is to anonymize clinical data and complying with regulations mandated by HIPPA.

Protecting patient sensitive information and system crucial data

Responsible for working with scientists and clinicians to handle data, transform and report back in the format requested

Collaborated with team to identify deliverables, technical tasks and resources required to complete a project, specifically as it pertains to technical tasks and deliverables.

Deployed projects using latest technologies

Strong ability to identify risks and mitigate risks

Detail oriented with a concern for quality

June 2001-2002

Philip Morris, VA Business Analyst

EDUCATION & CERTIFICATIONS.

Bachelor’s in computer science

Pune University, India

Core Strengths: Contract Manufacturing, Product Development, Strategic Sourcing, Governance, Medical Devices, Nano Technology, SOP, CAPA, GxP, cGMP, 21 CFR Part 11 Compliance, HIPAA Compliance, GDPR, HMI, PCI, Robotic process automation, Business Analytics, Budgeting and Forecasting

Working knowledge of business management software IBM Maximo, Syncade, LIMS, SAP, ERP, CRM, Data Warehousing, Azure, AWS, SaaS, Scrum, Sprint, Agile, JIRA, Kanban

Tools: MS Project, Word, Excel, Viso, Power Point, Eclipse, ANT, Workday HCM DICOM, HL7, Data Analytic Tools Tableau, IBM Cognos, Qlik

Languages: Core Java, Advanced Java, VB, SQL, PL/SQL, C, C++

Internet Technologies: HTML, DHTML, JQUERY, XML, AJAX, JSP, Servlets, JavaScript, ASP, Spring, Hibernate, XML, XSL, Cloud Computing, SaaS

Web Servers: Weblogic 10/9.2/8.1/7.0/6.1, Apache with Tomcat 3.1

Testing Tools: Win Runner, Rational Site Check

RDBMS: Oracle 10g/9i/8i/8.0x/7.x, DB2, MS-SQL Server 7.0/6.5, Sybase, MS Access

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