Aery

Email: ac2igb@r.postjobfree.com

Ph. 267-***-****

PROFESSIONAL SKILLS

Almost 5 years of experience in Validation and business analyst of Quality systemsequipment are, cleaning and software validation and technical writing of Validation protocols, SOP’s in pharmaceutical, medical devices and healthcare industries.

Good understanding and expertise in writing Good Documentation Practices (GDP) in FDA regulatedenvironment.

Experience in cGxPs (cGMP, cGLP, cGCP)environments in compliance with FDA 21 CFR part 11and 21 CFR part 820 and GAMP 5.

Excellent experience in the validation of highly regulated enterprise level business systems Quality Tracking Systems (TrackWise), Adverse Event Reporting System (Argus 6), Laboratory Information Management System (LIMS).

Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS).

Proven ability in development and execution of Validation plans (VP), Validation Protocols (IQ, OQ and PQ), RiskAssessments, Requirement Traceability Matrix (RTM) and Summary Reports (Validation and Test Summary Reports, VSR/TSR)

Experience in writing Validation Plan and Validation Reports for systems used in GxP environments.

Hands on experience in performing SAT (Site Acceptance Test), FAT (Factory acceptance test), IQ, OQ and PQ testing for instruments and equipment’s.

Developed applicable test cases for integration test, system test and acceptance test. Defects are tracked while processing testing and reported using HPALM.

Development and Execution of Process and Cleaning Validation & Verification protocols.

Experience in performing Gap Analysis, reviewing and performing Corrective and Preventive Actions(CAPA) and suggesting the Remediation Plans to mitigate the non-compliance.

Developed Standard Operating Procedures (SOPs) and trained users on SOPs for many analyticalinstruments and manufacturing methodologies.

Experience in technical writing/documentation expertise, including writing, editing and producing system user guides, operations procedure manuals, manufacturing process SOPs and protocolsmethods and procedures analysis, project coordination, training and support.

Experience in preparing quality control documents and prepared training materials and technical reports for multinational companies.

Conducted User Acceptance Testing (UAT) to check the various functionalities and to make sure that all the user requirements are met and documented UAT summary reports.

Experienced in validating semi-automated and automated packaging lines.

Involved in the development and execution of protocols for validation of PLC upgrades for different equipments such as Laser etching systems, 5 cu ft. blenders etc.

Experience in reviewing test cases and scripts and documented the results as per the FDA and ISO 13485 regulations.

Highly motivated individual able to grasp complex software and learn quickly.

Strong ability to work within tight deadlines.

Worked on Change Control Documentation such as Change Request Form (CRF), Change ControlImplementation Plan and Change control summary report.

Good experience in using documentum.

Validated non- functional deliverables like various reports, custom calculations, method parameters, workflow, test methods, etc. with the help of business users in the systems.

Good communication, technical writing and documentation skills.

Excellent teamwork and problem-solving skills.

Ability to work independently without much direct supervision, quick learning ability, good verbal writing, very strong analytical skills and ability to work in any type of environment.

PROFESSIONAL EXPERIENCE

Allergan, Cincinnati, OH Jun 2016 – till date

Validation Engineer

Development and execution of IOQ and verification protocols in Packaging equipment’s.

Validation in accordance to FDA regulations and checked to ensure compliance with 21 CFR part11 requirements.

Responsible for documenting the User Requirements, Validation Plan, Validation Summary Report, and Performance Qualification test cases.

Expertise in developing and documenting all the aspects of IQ, OQ, PQ and Validation Summary Report (VSR).

Experience in execution plan development, establishing site quality system to align with execution plan, engineering studies, verification, qualification planning, documentation and testing.

Responsible for documenting Process Validation and Verification Reports in packaging.

Involved in conducting Engineering studies, Process Qualification runs for Packaging equipment’s.

Initiated workflow and tracked status of all the documents.

Involved in the Installation, Operational and Performance qualification of semi-automated and automated packaging lines.

Involved in troubleshooting to successfully complete the testing of the Solid Dosage Packaging Equipment.

Applied CAPA to address the deviations in SAT.

Responsible for development of documentation to support commissioning and User Requirement Specification (URS).

Validated Electronic Record and Electronic Signatures in accordance to the FDA guidelines.

Involved in project teams to ensure that documentation prepared during project execution meets the requirements necessary to support the verification process.

Developed operational SOPs and trained the operators.

Hospira, KS Oct 2014 – May 2016

Validation Engineer

Collected user requirements from business users for TrackWise applications as apart of business analyst role.

Involved in the Installation, Operational and Performance qualification of semi-automated and automated packaging lines.

Validated Electronic Record and Electronic Signatures in accordance to the FDA guidelines.

Involved in drafting and execution of Remediation Plan and Gap Analysis.

Acquiring all the lab data electronically at its source and a full complement of instrument interfaces.

Queried on the application to find out the different stability studies and generate various summary reports.

Responsible for Inventory Management and periodic review of the laboratory applications

Resolved all deviations raised during execution byCAPA(Corrective Action Preventive Action), where required.

Responsible for documentation of all aspects of the Computer System Validation Life Cycle deliverables in accordance with 21CFRPart 11 and 21CFRPart 820and GAMP 5.

Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.

As a part of business analyst role reviewed test cases and scripts and documented the results as per the FDAand ISO 13485regulations.

Drafted Test Specifications (IQ, OQ, PQ) forDatacenteractivities.

Experience in technical writing/documentation expertise, including writing, editing and producing system user guides, operations procedure manuals, manufacturing process SOPs and protocol methods and procedures analysis, project coordination, training and support.

Document, investigate and obtain resolutions for deviations obtained in IQ/OQ/PQ execution.

Prepared Standard Operation Procedures (SOP’s) by adhering to cGMP standards and other appropriate regulations.

Executed Test scripts developed by other team members.

Developed Test Summary Report(TSR) based on the execution of test scripts.

Developed applicable test cases for integration test, system test and acceptance test. Defects are tracked while processing testing and reported using HP ALM.

As a part of business analyst role conducted User Acceptance Testing (UAT) to check the various functionalities and to make sure that all the user requirements are met and documented UAT summary reports.

Testing documentation development, review, pre-approval, execution, and post-approval of IQ, OQ, and PQ test scripts.

Used HPALM for bug tracking, reporting and following up with development team.

As a business analyst role authored Validation Reports to capture the results of Validation Testing and status of Validation.

ASPEX, TX Jun 2013- Oct 2014

Validation Analyst

Followed good test practices to document the test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.

Participated in Validation Life Cycle (VLC) planning, implementation and documentation

Developed Validation Master Plan (VMP) and validated the process to comply with the FDA rules and 21 CFR Pat 11 regulations

Maintained and ensured the accuracy of the requirements in URS and FRS by assigning the critical parameters to each of the user and functional requirements.

Closely interacted with designers/architects and software developers and prepared the Design Specification (DS) document.

Involved in validating the application, along with the Compliance team, according to CFR Part 11 requirements.

As a part of business analyst role performed Installation and Operational qualification of packaging lines for the PLC programs on equipments.

Drafted and executed validation protocols for PLC upgrades on equipments such as Laser etching systems on packaging lines.

Working knowledge in using RsLogix 5000 for PLC code compare and PLC program testing.

As a part of business analyst role assigned tasks to work on Test Specifications (IQ, OQ, PQ), Application Design Specifications and Operational Handbook.

Executed the test cases using Quality Center and documented results as part of IQs, OQs and PQs.

Reported the defects in the execution of the test scripts to the developers using Defect Tracking Tools likeQuality Center and updated bug report status

Reported to the developers about updates and change defects in the execution of the test scripts and test cases using Quality Center.

Allergan Inc., TX Apr 2012 -May 2013

Validation Engineer

Development and execution of cleaning validation and verification protocols.

Involved in equipment evaluation and residual sample site selection.

Involved in transition from manual validation system to automated validation using CIP Skid/COP systems.

Conducted dirty hold time and clean hold time studies.

Aligned Cleaning Validation SOPs with external manufacturing site SOPs for gap analysis, site Assessment.

Executed protocols for PLC based equipments and helped in debugging the PLC code.

Involved in drafting Standard Operating Procedures (SOPs) and User Manuals for the equipment usage and maintenance of equipment.

Generated Validation Summary Report (VSR) to summarize and document all Validation activities related with equipments.

Participated in equipment failure investigations and Corrective and Preventive Action assessments (CAPA).

Interacted with Subject Matter Experts (SME) to understand and document the workflow and functionalities on different modules used in System.

Prepared protocols for following cGMP and cGLP procedures.

Performed Gap Analysis and initiated Remediation Plans in case of non-compliance with 21CFR Part 11 and EU Annex 11.

Generated and updated supporting documentation such as material and equipment specifications in accordance to the required standards.

Experienced in using Trackwise, ABACUS for asset management as well as documents control.

Developed appropriate cleaning procedures in accordance to the equipment parameters, residues and cleaning agent’s characterization for pH meters and centrifuges used at facility.

Developed operational SOPs and trained the operators.

Involved in validating laboratory equipments.

Involved in conducting GAP analysis, authoring deviation reports and setting up of a Remediation Plan.

Validation in accordance to FDA regulations and checked to ensure compliance with 21 CFR part 11requirements.

Responsible for documenting the User Requirements, Validation Plan, Validation Summary Report, and Performance Qualification test cases for the lab instruments.

Expertise in developing and documenting all the aspects ofIQ, OQ, PQ and Validation Summary Report (VSR).

Experienced in Technical Writing and Report Generation.

Wrote and reviewed the system related SOPs to ensure compliance of company’s process, policies and procedures.

Conducted Manual Tests and for all the functionalities of the application.

Analyzed and documented Business Requirements and developed Master Test Plan.

Developed Requirements Traceability Matrix (RTM) to track requirements and to align the work process.

Worked closely with users and the vendor to understand and document user requirements and functional design specifications.

Responsible for daily project status updates to management and discussed milestones and tasks.

Performed Gap Analysis and developed Remediation plan, also maintained and documented SOPs.

Matrix Labs, India Jun 2011 - Jan 2012

Validation Analyst

Associated with Engineering Departments, Quality Control and Quality Assurance teams

Trained on maintaining protocols and documents for quality purposes

Created and updated SOPs as per cGMP rules

Identification of root cause for the deviations and Implementing CAPA plans

Reviewed pre and post market summary reports to ensure compliance with FDA regulations

Involved in documentation of technical manuals, data flow diagrams, requirement documents etc.

Prepared validation protocols - IQ’s. OQ’s, PQ’s

Developed Remediation Plan to bring the system in compliance with GxP.

Drafted Validation Summary Reports.

EDUCATION BACKGROUND

Bachelors in BIOINFORMATICS at SATHYABAMA UNIVERSITY, India

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