Information Security Medical Device

Anudeep Reddy

*******.*******@*****.*** 347-***-**** https://www.linkedin.com/in/anudeep-r-032752146/

Sr Consultant with strong experience in Medical Device & Pharmaceutical Industries with Edwards Lifesciences and Johnson&Johnson (McNeil Consumer Healthcare). My career has included Equipment Validation, Process Validation, Packaging, Cleaning, Facilities, Computer System Validation and Regulatory Compliance.

EDUCATION: MS, Information Security Management Systems and BS, Pharmacy.

TECHNICAL SKILLS:

Validation Deliverables: Validation master plan (VMP), Validation test plan, URS, FRS, DS, IQ, OQ, PQ Protocols, Requirement Traceability Matrix (RTM),Failure Mode Effects and Analysis (FMEA), Validation summary reports, Test summary Report, system release report, Risk Assessment, Retirement plan, DOE’s TFIQ (Tooling Fixtures Installation Qualification), TMV (Test Method Validation), DV (Design Verification), Material Qualifications, DHF (Device History Files), Aging Studies (Real time and Accelerating) and Technical Summaries for various processes.

FDA Compliance: ISO 13485, 21 CFR Part 11, 21 CFR Part 820, cGxP (cGMP, cGAMP, cGDP, cGLP), IQ, OQ, PQ, RTM, SOP, Work Instruction, Change Control, Risk Assessment, and vendor audit questionnaires.

Tools: Ignite, Documentum, HP ALM, Blue Mountain, Maximo, SQMS, ETQ, ERMS, Keyence, Empower, etc.

Edwards Lifesciences Oct. 2014 – pres.

Validation Lead / Validation Engineer (Contractor)

Projects:

Remediation Project in response to Form 483 in Draper, Utah Site. (SWV, IQ/OQ).

Remediation Project in Anasco, Puerto Rico Site (SWV).

Material Qualifications Project in Anasco, Puerto Rico Site.

Remediation Project for Balloons project in Irvine, California site (Lead – SWV Team).

Line Transfer Projects for EPC-MIS in Draper.

Gap Assessments for Packaging Validations (Audit readiness).

Transfer Project (Project IOWA EPC-MIS) to Lake region and Nordson.

Involved in corrective actions for CAPA 340.

Cardioband Stabilization Project in Irvine, California site (Lead – TMV team).

Cleaning Validation Project for Israel (Lead) and Ireland (Lead) sites.

Lead Cardioband Implant TMV’s team for Singapore plant.

Process Validations for Esheath and various THV lines in Draper.

NOC project for Supplier Quality.

Sustaining Engineering for THV Manufacturing Lines (THV Sheaths and Shafts)

Supplier Development Project (Evoque)

Supplier Cleaning Validation Project (Cirtec, Integer and Duke Emperical)

eSheath X (R&D Phase1) and Scroll R&D Projects (On-going)

NPD – THV OPTIMA

Validation Lead / Validation Engineer (Contractor)

(R&D, Quality, Supplier Development, Manufacturing- Sustaining and Supplier Quality)

Lead a TMV (Test Method Validations) team, performed gap assessments and created a project plan for Cardioband Stabilization project.

Extensive experience in drafting DFMEA, PFMEA and AFMEA.

Worked on Global validation projects for Multiple Class III medical devices.

Performed EU-MDR DHF Remediations on diff manufacturing lines and closed identified gaps.

Involved in Remediation gap assessments and validations.

Performed gap assessments for the manufacturing equipment and manufacturing processes in response to FDA audit findings (FORM 483).

Performed SIP/CIP studies for Tissue cleaning line.

Performed process validations (IQ/OQ/PQ), Software V&V, TMV’s for various manufacturing lines within Edwards.

Qualified Toyo Molding Equipment (Draper) and Arburg (PuertoRico) by performing IQ/OQ/PQ.

Involved in Manufacturing line transfers and New Product Development.

Qualified various PLC’s and HMI’s (Allen Bradley, Keyence)

Executed various Ladder Logic Codes on Manufacturing Equipment

Expertise in end-to-end qualification of Equipment and Process.

Ensured that the process complies with the 21 CFR part11 and 21 CFR Part 820 standards

Identified root causes and authored CAPA for observed deviations during the qualification process

Qualified materials (Resins / plastics) for various manufacturing products.

Conducted Aging studies for packaging validations (Accelerated and Real time).

Hands on statistical analysis tool (MINITAB) for Gage R&R studies, Normality Analysis etc.

Qualified large number of manufacturing equipment performing (IQ/OQ/PQ), Software V&V and TFIQ’s.

Investigated for the root cause (CAPA) for all observed deviations during remediation.

Gap Analysis on DRD (Design Requirement Document), FMEA’s including Design, Process and Application.

Performed Cleaning validation qualifications in Draper and Israel sites (THV and Cardioband).

Drafted SOP’s and Work Instructions for various equipment’s and processes.

Qualified Freezers, Ovens, Incubators and Autoclaves using Temperature mapping studies and Biological Indicators.

Performed Test Method Validations for Manufacturing and Incoming inspections (Attribute and Variable).

Developed technical SOW documents and estimate time and resources needed for projects

Solved qualification and validation execution issues using critical analysis skills; ensures alignment with client directives and industry guidelines on validation.

Performed FAT, SAT, IQ/OQ/PQ on different types of manufacturing and Lab equipments.

Worked on DFMEA's and PFMEA's for Critical Care Remediation project (2016-17)

Redlined Packaging sections of DFMEA's for Project Orion Gap Assessments (SSH-2018)

Knowledge and Experience on Edwards 4 point and 5-point severity FMEA templates.

Redlined FMEA’s per new severity scale and process improvements.

Knowledge on Risk Assessments and ranking per SOP's.

Drafted PQP’s for Production Part Approval Process from suppliers.

Ensured validation and qualification activities of products, processes, methods, facilities, utilities and equipment comply with internal requirements and applicable regulations and standards.

Performed Characterization studies (notebook studies) for manufacturing equipment (Vertical Laminators, Tip Bonders etc.)

Drafted NOC’s and worked with cross functional Teams in approving the changes.

Performed PPAP, FAI, PQP and commercial readiness for R&D project.

Worked with multiple suppliers in performing Supplier Process Validations and Cleaning Validations.

Created and routed around 80 Change Controls for Supplier Development (R&D) project.

Performed Cleaning Evaluations and Cleaning Geometry calculations for Evoque and Evoque EOS.

Reviewed and approved supplier IQ/OQ/PQ for cleaning validations (Equipment and Process).

Initiated Quality Laboratory Studies and worked with cross functional teams in closure of the EQL’s.

Performed Design and Product verification tests.

Worked with suppliers in creating fixtures, calibrating and qualifying the fixtures.

Performed gap analysis on DHF’s for EPC-MIS products and closed the gaps.

Prepared Tech Transfer files for various Manufacturing Line Transfer Projects.

Johnson & Johnson/McNeil Consumer Healthcare May 2013 - Sept. 2014

Validation Consultant (Consent Decree) (Contractor)

Projects:

ETQ (Excellence through Quality) - CAPA Module Validation Project.

CSCCM (Cold Stream Cold Chain Manager) Validation Project.

ERMS (Electronic Records Management System) Validation and Data Migration Project.

Collected User requirements, Business requirements and Functional requirements (URS, BRS, FRS).

Validated CAPA Module for EtQ application.

Well experienced in drafting test scenarios to test requirements and document requirement traceability.

Developed, reviewed, revised or approved Standard Operating Procedures (SOP’s) as required.

Developing documents and authoring reports for periodic review of equipment including QA procedures like, field sampling, analytical facilities and instrument maintenance, document comparisons and data reporting.

Validated various Report generating modules in ERMS system and involved in Data migration from legacy to target (ERMS) system.

Ensured compliance with 21 CFR Part 11 by documenting and executing validation protocols IQ’s, OQ’s and PQ’s for the equipment.

Collected User requirements, Business requirements and Functional requirements (URS, BRS, FRS)

Worked on Computer System Validations for EtQ, ERMS (Electronic Records Management System) and Sensitech CSCCM systems.

Developed, reviewed, revised or approved Standard Operating Procedures (SOP’s) as required.

Actively participated in project meetings and review

Maintained Requirements Traceability Matrix to keep track of the changing requirements

Executed IQ verification scripts and supported DEV team resolving issues within Quality and Production Environments.

Maintained Requirement Traceability Matrix pertaining to CAPA module throughout the project.

Involved in Sensitech CSCCM Validation Activities.

Executed User Acceptance Test Scripts (UAT) for Sensitech CSCCM.

Identified system issues and resolved the issues.

Logged in Test Development issues in SharePoint and verified the fixes with Technical Team

Validated Sensitech CSCCM software by using TempTale Monitors which records the time and temperature of shipments.

Prepared, maintained or reviewed validation and compliance documentation such as engineering change notices, schematics, and protocols.

Education:

Masters in Information Systems Engineering Management.

Masters in Project Management (On-going)

Bachelors in Pharmacy

Contact this candidate