Validation Specialist Resume

SUMMARY

Over 5 years of validation experience in Computer Systems, Quality Systems and Instruments / Equipment’s in Pharmaceutical, Medical Devices and Biotechnology Industries, with profound knowledge of current validation practices, predicate rule, FDA, 21CFR Part 11(210/211), cGXP (cGMP, cGCP, cGLP), SOPs, PV,SDLC. Possess diverse experience in Technical Writing and Validation Analysis.

TECHNICAL SKILLS

Computer System Validation: FDA compliance, 21 CFR Parts (11, 58, 210, 211, 820), GxP, VMP, VSR, IQ/OQ/PQ, SOP, RTM, SOX, Audit Trails, Gap Analysis, SDLC, VLC

Software: LIMS, AERS, Documentum, TrackWise, Sharepoint, Quality Tracking System, ARGUS Safety Management System

Operating System: MS Windows

Laboratory Equipment: HPLC, GC, Autoclaves, Sterilizers, Incubators

Others: MATLAB, Advanced knowledge of MS Office(Word, Excel, Access), Adobe Acrobat

Programming: C, C++,Java

Methodologies: Agile, Waterfall

PROFESSIONAL EXPERIENCE

Confidential

Validation Specialist

Responsibilities:

Assessed the company’s current validation status preceding an internal audit.
Involved in preparation of Validation Master Plan and documented all aspects of CSV including validation protocols like IQs, OQs, PQs in accordance with FDA regulations.
Interacted with end users and vendors to gain understanding of user and functional requirements of Argus safety.
Generated and reviewed SOPs for the validation of various modules of AERS.
Prepared Validation Summary Report based on data derived from tests.
Performed Gap Analysis on the system and determined Remediation Plan for systems that were partially compliant or non compliant with cGMP guidelines.
Created Test Cases for each functionality of the AERS application.
Provided status updates on projects as per management requirements.

Confidential

Validation Analyst

Responsibilities:

Write, edit and review scientific and technical documents (Standard Operating Procedures, Product Specifications) and assist project teams in collecting and organizing information.
Prepare, maintain, or review Test Method documents to record changes in methods.
Complete documents and other assigned tasks within established timelines and with high quality in terms of scientific content, clarity, accuracy, format, consistency and adherence to regulatory and internal guidelines, style and processes.
Utilize Master Control system to schedule review of documentation and drive effectiveness within target timelines.
Access Change Control activities on TrackWise system to make necessary changes to the document and work towards getting the document effective.
Time management of documents going through Change Control process to meet the required deadlines.
Submit Service now tickets and follow up regularly to get the LIMS build updated for each revision.
Close incident reports after the document goes effective.
Maintain standardized language and documentation practices that allow consistent execution of defined activities.
Complete data entry in Laboratory Information Management system (LIMS) and run reports.
Generate Certificate of Analysis (CofA) in LIMS to summarize all the testing performed on the referenced product or material demonstrating its acceptance against certain specifications.
Communicate key milestones and deliverables including follow up and active communication on issues and potential roadblocks.
Create Performance metric to record productivity results of all the labs by every month - end.
Work with Training coordinators to ensure that training requirements are up to date.
Involvement in other QC activities such as Records Retention, if required

Confidential

Quality Tester

Responsibilities:

Ensured the adherence to Register SDLC and application development policies and procedures.
Coordinated with Development and Validation team to facilitate discussions around the technical aspects of the system, as defined by the project plan.
Responsible for Validation Plan development, review, approval and maintenance.
Supported the assembly of the Functional and Design Requirements Specification documents of the Regulated system.
Performed independent review and approval of initial commissioning, decommissioning, qualification (IQ, OQ and PQ) and validation life cycle documents and subsequent changes.
Reviewed the submission of final packages of internal documentation for compliance with regulations and industry guidelines.
Co-ordinated in the Data Migration of Reports module from Trackwise.
Pre-reviewed and Post-approved the executed test scripts in HP Quality Center.
Assess impact to changes in systems, equipment, process and instrumentation and review and approve Change Controls.
Reviewed the entire validation life cycle/SDLC deliverables from initial stage of Validation Master Plan to Validation Summary Report.
Coordinated with the Site’s QA teams to ensure the new protocols have been executed and verified in compliance with the regulatory standards including the predicate rules.
Reviewed and approved pre execution and post execution protocols in HPQC.

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