Naveen M

Email: adbyqq@r.postjobfree.com

Phone: 732-***-****

PROFESSIONAL SUMMARY:

Validation Engineer with more than 7.5 years of experience in Healthcare Industry responsible for the design/ develop/ improve/ source manufacturing processes, equipment/ tools, and systems. Evaluated process and product design for manufacturability and suggest improvements for quality, cost reduction, and efficiency. Authored, executed, and summarized validation protocols. Coordinated and managed validation project execution for equipment, critical utility, process, cleaning, and computer related systems. Ensured protocols, records, and procedures are in compliance with applicable FDA and ISO regulations and current Good Manufacturing Practices (cGMP).

TECHNICAL SKILLS:

FDA Quality system regulations, 21 CFR Part 11 (210, 211, 50, 820), protocols (IQ, OQ, PQ) cGXP (GLP, GMP), Standard Operation Procedures (SOP), LIMS, AERS, Gap Analysis, RTM, Audit Trials and Remediation

Tools: MS Office (Word, Excel, PowerPoint, Access), Documentum, Quick Test Pro and Quality Center, Procal, Midas, Nugenesis

PROFESSIONAL EXPERIENCE:

Merck & Co Inc West Point, PA

Sr. Validation & Compliance Engineer October 2018 – Present

Authored Requirement Specifications & Configuration Specifications (RSCS), Installation Qualification, Operational Qualification, User Acceptance Testing, for COTS (Commercial Off-The Shelf) systems.

Authored Requirement Traceability Matrix, Quality Assurance Summary Reports and Version control for COTS (Commercial Off-The Shelf) systems.

Draft wrapper documentation for the vendor provided Installation Qualification & Operational Qualification documents.

Executed the Installation Qualification, Operational Qualification, and User Acceptance Protocols for the different Laboratory Systems and associated software’s.

Communicate daily operations of validation team to the management to make sure that protocols and reports are generated, reviewal and approvals within predetermined timelines.

Responsible to gather the information to expertise in validating the Laboratory Systems used for GxP purposes in compliance with 21 CFR Part 11.

Update Standard Operating Procedures (SOP) for the Laboratory COTS Systems to incorporate the updates from the previous versions.

Generate Instrument Identification Numbers, PM Plans and Calibrations for the Laboratory Systems in ProCal Application.

Create templates for 21 CFR Part 11 assessment and verified the documentation is in compliance with the DICOE (Data Integrity Centre of Excellence).

Create System Document Index (SDI) for Laboratory System and/or associated software.

Involve in US-FDA (Food and Drug Administration) Audits and provide proper documentation upon the request to support the GMP (Good Manufacturing Practices).

Perform gap analysis and developed remediation plan for compliance with Data Integrity.

Author method transfer/method validations, as applicable, for deployment of Waters arc/Agilent HPLC/Waters UPLC using Empower 3 software.

Ensure completeness of testing via development of traceability matrices that map requirements and specification to testing.

Create and maintain all validation documents ensuring compliance with internal company standards and health authority regulatory requirements.

Worked with a variety of instruments including Liquid Particle Counter, Capillary Electrophoresis System, Plate readers, Spectrophotometer, Titrators, pH/Conductivity/Ion Meters and Balances.

Needle Tech, Attleboro Falls, MA

Sr. Validation Engineer Jul 2015 – Oct 2018

Reviewed new projects from regulatory standpoint and ensured part 11 assessment is completed and review

of all evidences and evaluations are done before project goes live.

Completed 21 CFR Part 11, GxP and Functional Risk Assessment for various manufacturing and testing

systems.

Developed Validation Plan to outline activities, deliverables and roles and responsibilities.

Responsible for review and approval of validation documents including but not limited to Validation Plan, Installation Qualification Protocol (IQP), Operational Qualification Protocol (OQP), Performance Qualification Protocol (PQP), Test Plans, Traceability Matrix, Validation Registry Checklist

and Validation Summary Report.

Developed and verified Periodic Review plan, Back-up and Disaster Recovery plan and Change Control plan for post-deployment support.

Attended requirements gathering sessions, reviewed System Design Specifications and System Baseline

Configuration.

Hands-on experience in using tools like HP-QC/ALM.

Created Testing Documentation including Test Plan, Test Cases, Test Scripts, Requirements Traceability Matrix (RTM), Defect Report and Test Summary Report.

Highly skilled at using Document Management Systems like SharePoint, CORAL, Pilgrim, HP,Quality Center

ALM for document archiving, storage and indexing

Used Quality Management tools such as HPQC to manage requirements, test plan, test scripts and defects.

Managed defects by ensuring that proper documentation and corrective actions have been implemented.

Participated in Defects Resolution process by coordinating with Developer, Application Manager and SME.

Reviewed Requirements Traceability Matrix to ensure that all the requirements are appropriately tested in designated test phases.

Closely worked with business representatives to provide guidance on creation of User Acceptance Test (UAT)

scripts during implementation.

Review and approvals of execution of IQ, OQ and PQ Scripts.

Summarized Validation activities, test results, and open issues in the Validation Summary Report.

Lonza, Walkersville, MD

Validation Engineer May 2013 – Jun 2015

Reviewed existing Standard Operating Procedures (SOP's) for System Administration.

Revised Change control Procedure and Testing SOP's.

Gathered User Requirements from Business process owners.

Reviewed URS (User Requirements Specification).

Ensured process and product quality during the processing steps of solid dosage manufacture, such as weighing, granulation, coating, drying, compression, and encapsulation.

Reviewed FRS (Functional Requirements Specification) document and DS (Design Specification)

documents.

Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Quality Assurance review, Validation Summary Report in compliance with 21 CFR Part 11 and GxP FDA Compliance Regulations.

Developed Test Plans, Test Cases using HP Quality Center.

Responsible for performing gap analysis of executed validation reports for solid dosage forms to ensure compliance with NDA requirements, regulations and company policies and procedures.

Responsible for reviewing Installation Qualification (IQ)/Operational Qualification (OQ)/Performance

Qualification (PQ) test scripts.

Coordinated UAT (User Acceptance Testing) for the application.

Involved in reviewing Corrective Action and Preventive Action (CAPA) documentation.

Validated the Integration of the CAPA Workflow with the other business workflows and the interfaces for the Track Wise workflow.

Developed Test Cases for Functional and Regression Testing.

Took part in weekly status meetings with Project leads, team leads and subject matter experts to update work progress.

Reviewed protocols for Audit Trail, time stamp and electronic signature for workflow of documents.

Worked with MS Visio to create workflow models and process flow models after reviewing URS and FRS.

EDUCATION

Master of Science, Analytical Chemistry April 2011 OSMANIA University, Hyderabad, INDIA

Bachelor of Science, Bio Technology April 2008 OSMANIA University, Hyderabad, INDIA

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