Durga S. Jammalamadaka

Ph: 732-***-**** E-mail: acovu6@r.postjobfree.com

PROFILE

* *****' experience as a Technical Analyst/Writer in

medical/pharmaceutical and medical device industry.

SKILLS:

. Extensive knowledge of MS Word, MS Excel, MS Powerpoint, MS Visio, MS

Project, Quality Center.

. Extensive experience in the implementation, integration and validation of

computer system

. applications in environments regulated by GDP, GMP, SOP, GCP, 21 CFR Part

. 11/820/210/211, ISO 27001.

. In-depth knowledge of industry standard methodologies like SDLC, STLC,

Waterfall

. methodology, Agile methodology etc.

. Experience in designing test cases and test scripts in Quality center and

manual testing.

. Expertise in Regression, Black box, Positive and Negative testing and

Defect Management

. and Tracking.

. Excellent written and verbal communication skills.

. Experience in preparing Gantt charts to determine progress of various

deliverables pertaining to a project.

. Experience in PID - Governance and organization structure.

. Experience in creating IQ, OQ, PQs for devices and applications.

. Design and delivery of Process Mapping Documents and key operating

guides.

. Focused on creating a clear and concise document by soliciting input from

Business

. Analysts, SMEs and Developers on need basis.

. Gathering inputs from related teams to produce clear and thorough

Disaster Recovery documents such as the BIA, DR Requirements, DR

Plan, TEP, TEP Summary etc.

. Experience acting as a DR Coordinator.

. Exceptional knowledge in laboratory analytical and sterilization

equipment such as Statim,Autoclave, Digital Radiology Equipment,

Triturator, High-speed Rotary Equipment in the medical field.

. CAPA as part of Root Cause Analysis.

. Well-organized and detail-oriented with the ability to work in a fast-

paced environment and

. handle multiple projects at the same time.

TECHNICAL SUMMARY:

1. Office Tools: MS Word, MS Excel, MS Powerpoint, MS Visio, MS Project.

2. Testing Tools: Manual testing, Quality Center, Quick Test Professional.

3. FDA/ISO Regulations: 21 CFR Part 11/820/210/211, SOP, GxP (GDP, GCP,

GMP).

4. Validation: SDLC, STLC, Waterfall methodology, Agile methodology.

Experience

Celgene, NJ

(October 2013-Present)

. Celgene is a leading cancer drug producer in the medical industry. My

role in Celgene is as a Disaster Recovery Technical Analyst/Writer and

I carry out the following functions and procedures:

. To carry the duties of a Disaster Recovery Coordinator and DR

Technical Writer.

. Covering several duties of the DR Manager and the DR coordinator in

their absence or under their supervision.

. Deep knowledge of Disaster Recovery / Business Continuity procedures.

. Develop and draft technical DR documentation, templates and other

related documents.

. Gathering inputs from related teams to produce clear and thorough

Disaster Recovery documents such as the BIA, DR Requirements, DR Plan,

TEP, TEP Summary etc.

. Ability to follow system design documents, SLAs and prepare

documentation for varied applications pertaining to Disaster Recovery.

. Basic infrastructure and Data Center operations.

. Extensive knowledge of regulatory terminology (21 CFR Part 11).

. Experience in Power Point presentations, Visio, Word and Excel.

. Experience in drafting DR test procedures.

. Experience coordinating and developing DR plans.

. Coordinate with and gather input from related teams in order to

document procedures and methodologies to be followed during an actual

crisis( ISO 27001).

. Expertise in making Visio presentations in system architecture and

network diagrams based on input from other teams.

. Hands on experience conducting DR test exercises.

. Ability to shift priorities and handle multiple deliverables

simultaneously.

. Developed Project Initiation Document - Organization, Governance and

Roles and Responsibilities. Worked very closely with the approval

teams.

. Prepared Gantt Charts using MS Project to determine deadlines for

project deliverables.

Smart Practice, NJ

(Mar 2012-Oct 2013)

Smart Practice is a leading provider of clinical supplies and office

essentials to help deliver excellent patient care in medical and dental

offices. In this project I worked in the capacity of a Documentation

Specialist in the Dental Supplies and Distribution Department.

5. My role was to ensure proper documentation of product distribution and

storage in accordance with cGMP guidelines.

6. Audit Management and Document Management as part of LIMS.

7. Experience in creating IQ, OQ, PQs for devices and applications.

8. Create workflows, Flow charts and Diagrammatic Representations of

various Distribution practices.

9. Ensure proper distribution and transportation methods are followed by

creating clear and concise technical documents keeping in view the

personnel involved in various departments.

10. Implementation, integration and validation of computer system

applications regulated by GMP, GDP 21 CFR Part 11/210/211.

11. Create SOPs for various dental products that are marketed by the

company keeping the end users in mind.

12. Create Incident Management Reports with regard to Disaster Recovery.

13. Consult with various departments, SMEs and other personnel to ensure

proper documentation of various processes.

14. Compare and deliver precise documents and graphs on similar products

manufactured by different companies versus their cost.

15. CAPA as part of Root Cause Analysis.

Integra Life Sciences, OH

(Feb 2008-Feb 2012)

Integra is a leading provider of surgical instruments, implants, devices,

equipment care and cleaning products. It is a major supplier to various

hospitals, medical and dental offices. In this project, I worked with the

Dental Products Team as a Technical Analyst.

. My role was to prepare user manuals, technical documents on various

Miltex products such

. as Dental instruments and sterilization chemicals.

. Implementation, integration and validation of computer system

applications regulated by

. GDP, GMP, SOP, GCP, 21 CFR Part 11/820/210/211.

. Experience in creating IQ, OQ, PQs for devices and applications.

. Experience in preparing Gantt charts to determine progress of various

deliverables pertaining to a project.

. Manage and create validation documents including Test Plan, Test

Specifications and

. Defect and Summary reports using Quality Center.

. Interacting with customers to determine test conditions with expected

results.

. Create workflows using Microsoft Visio to help understand the flow of

application.

. Creating workflows and Data Tracking support using LIMS.

. Audit Management and Document Management as part of LIMS.

St. James hospital, NJ

(Jun 2006-Dec 2007)

St. James was a hospital that served all sections of people in the Newark

area of New Jersey. I worked in the capacity of a Technical Writer.

16. In this project my role was to test the suitability and productivity of

various medical / dental

equipment that would be used in the hospital.

17. Prepare technical documents and user manuals on varied medical and

dental equipment

such as radiographic machines, curing lights, Statim, Autoclave etc.

18. Prepare documentation on Incident Response and Disaster Recovery.

19. Perform positive, negative and regression testing to ensure suitability

of the equipment to

existing conditions/facilities in the hospital.

20. Designed and executed test cases and test scripts in Quality Center and

QTP.

21. Worked hand-in-hand with Business Analysts, SMEs and Marketing

representatives of

supplier companies to select and acquire suitable and cost-effective

equipment.

22. Compared and delivered precise documents and graphs on similar products

manufactured

by different companies versus their cost.

Jyothi Laboratories, India

(Jun 2002-Oct 2003)

Jyothi Laboratories manufactured chemicals that were used for sterilization

purposes, to conduct experiments and chemicals that acted as catalysts in

experiments. I worked a as a Junior Document Writer.

. My role was to document the usage of various chemicals, compare them to

the previous/existing version of the same chemical.

. Documenting any changes made to an existing chemical and any side effects

the new component may have on users and practitioners.

. Ensuring that their Clinical Management Trial System was in accordance

with FDA regulations.

. Prepared manual test plans, test cases and test scenarios according to

specifications.

. Performed positive and negative testing, regression testing to ensure

quality of the product.

EDUCATION:

BACHELOR'S DEGREE

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