SUMMARY

• Over 6 years of diversified experience in Technical Writing, Validation procedures and Quality Assurance in Pharmaceutical Industry with a strong background in performing Equipment Validation, Commissioning and Qualification, Cleaning Validation and Computer System Validation.
• Strong knowledge of FDA 21CFR Part 11: Electronic records and electronic signatures along with 21 CFR Part 50, 56, 58, 210, 211, 312, 314, 820.
• Good experience in GAMP4 and GAMP5 practices.
• Strong experience in Analytical Instrument Qualification (AIQ).
• Strong knowledge of Software Development Life Cycle (SDLC), Computer System Validation (CSV) and Validation Lifecycle (VLC).
• Validated QC lab equipment per USP section 1058, FDA part 11,210,211,820
• Experience in developing Validation deliverables in compliance with cGMP, GAMP, cGLP, and cGCPs.
• Experience with entire life cycle of Computer Systems Validation including User Requirement Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment (VA) and System Design Specifications (SDS).
• Experience in periodic review of the systems for Validation maintenance.
• Experience in developing protocols, Executing tests and Summary Reports for IQ, OQ and PQ for validations in various pharmaceutical companies.
• Created and Executed Site Acceptance Test (SAT) Protocol for whole packing line and Drafted Final Summary report.
• Identified Exceptions in SAT and addressed deviations by Corrective and preventive actions Plan (CAPA).
• Development and Execution of Process and Cleaning Validation & Verification protocol.
• Expert in medical device and verification.
• Expertise in swabbing procedures, for different cleaning validation techniques like Total Organic Carbon (TOC) and GC/LC/IC.
• Experience in writing and reviewing Computer System Validation Plan/Remediation.
• Extensive experience in writing and reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs) and Requirement Traceability Matrix (RTM).
• Excellent Coordination skills, Communication Skills and strong Technical Writing skills and a good team player.
• Certified Six Sigma green belt.

TECHNICAL SKILLS

Validation: IQ/OQ/PQ Protocols, FDA Regulations, 21 CFR part 820,21 CFR part 11, ISO1, ISO 1 GAP Analysis, GxP (cGMP, GCP, GLP, GDP) Environments, VMP, RTM, SOP, Audit Trails, LIMS

Equipment: Tanks, Drying and Stability chambers, Autoclaves, Sterilizers, packing equipment, Auto sorting machine, Lyophilizers, HPLC, TOC analyzer, Osmometers, Microbeta, LabX, Syngene, Labchip, SoloVP withCary - 60 spectrophotometer, Spectrophotometers, Mass Spectroscopy and Plate Readers, Incubators and Shakers

Computer Systems: Valgenesis2.0, Computerized Maintenance Management System (CMMS), LS domain Stela Training Module, Track wise, Salesforce, SAP

PROFESSIONAL EXPERIENCE

Confidential, Lexington, MA

Validation Engineer

Responsibilities:

• Validated Analytical lab equipments like Mettler Toledo Titrators using LabX software, Perkin Elmer Microbeta Scintillation Counter and UPLC’s, Syngene, ARTEL Multichannel Verification System, Lab chip for Electrophoresis, tanks, Incubators, Shakers and some other Lab equipments.
• Created and Executed Site Acceptance Test (SAT) Protocol and Drafted Final summary report.
• Reviewed and approved Validation Protocols (IQ, OQ and PQ) for HVAC, UFDF, Chromatography, Centrifuges, Refrigerators, Freezers, and Incubators.
• System Periodic Reviews (Validation Maintenance) were performed following “Shire Validation Maintenance Procedure” and “Validation Maintenance Transition Plan”.
• Identified Exceptions in SAT and addressed deviations by Corrective and preventive actions Plan (CAPA).
• Involved in Validation Process and documentation of Validation Project Plan.
• Involved in gathering the User Requirements from the System Owners document for all the software components.
• Developed FRS (Functional Requirements Specification) and DS (Design Specification) from the URS (User Requirement Specification)
• Responsible for reviewing and documenting Validation Plan, OQ/PQ protocols and Validation Summary Report.
• Good experience in NuGenesis data management.
• Developed Requirements Traceability Matrix (RTM) to track requirements during the QA Testing Phase.
• Responsible for writing change control SOP’s to comply with 21 CFR Part 11 requirements.
• Wrote SOPs for each instrument at different levels in accordance with GAMP regulations.
• Verified that data for all the systems are backed up daily on the servers.
• Worked with IT to ensure compliance with Part 11 backup and restore requirements.

Confidential, Plainsboro, NJ

Validation Analyst

Responsibilities:

• Develop, maintain and reviewing of SOP’s for cleaning validation.
• Involved in collection and reviewing of data.
• Monitoring of cleaning water flow rates, cleaning time and water temperatures in cleaning cycles.
• Revalidation of equipment’s to increase its performance.
• Handled process equipment such as fluidized Bed dryer, Autoclaves, Heat Exchangers, Mixers, Tray dryer, tablet press and Coating, High Shear Granulators, Bin Blender, Control system
• Developing templates for validation plan, protocol and IOPQs.
• The project involved writing and executing cleaning validation/Verification protocols and determination of worst case scenarios.
• Authored and reviewed cleaning validation and verification protocols for manufacturing vessels and equipment.
• Performed manual Clean in place method of cleaning and documented for both clean in place (CIP), Sterilization in Place (SIP) and clean out place (COP) methods for cleaning.
• Created cleaning cycle development strategies and qualifications for a variety of equipment including: process vessels, chromatography skid/column, glass washers and parts washers.
• Selection of best swabbing procedures and performed swabbing in order to remove residues from the previous batch run.
• Validation of swabbing procedures according to standard laboratory specification.
• Executed cleaning validation and verification protocols.

Confidential, Woodcliff Lake, NJ

Validation Engineer

Responsibilities:

• Validated lab equipment like Solo VP with Cary-60 spectrophotometer, Spectrophotometers, Mass Spectroscopy and Plate Readers.
• Conducted GAP analysis to identify compliance of 21 CFR PART 11 and formulated Remediation Planning.
• Reviewing and re-authoring all cleaning documents projecting consistency and detail to meet industry standards and comply with regulations.
• Identified Exceptions in SAT and addressed deviations by Corrective and preventive actions Plan (CAPA).
• Reviewed and approved Validation Protocols (IQ, OQ and PQ) for Refrigerators, Freezers, Incubators.
• Worked under FDA regulations and strict GAMP environment.
• Managed system upgrades, enhancements, and maintenance in a cGMP environment
• Drafted Requirement traceability matrix (RTM) after qualification to identify Gaps.
• Generated and reviewed the validation deliverables with in specified time frames.
• Developed Validation summary reports.

Confidential, West haven, CT

Validation Engineer

Responsibilities:

• Involved in writing Functional Requirement Specifications (FRS).
• Validation in accordance to FDA regulations and checked to ensure compliance with 21 CFR part 11 requirements.
• Involved in Validation Process and documentation of Validation Master Plan.
• Conducted GAP analysis to identify compliance of 21 CFR PART 11 and formulated Remediation Planning.
• Developing templates for validation plan, protocol and IOPQs.
• Analyzed gaps and prepared Gap Analysis document and Remediation Plan.
• Developed Requirements Traceability Matrix to keep track of the changing requirements.
• Customized and validated LIMS modules and performed Data Migration.
• Developed OQ and PQ test scripts to meet approved requirements for LIMS project.
• Updated the Report Specifications documents for LIMS project.
• Assessed the risk involved in adding new modules.
• Preparing and documenting Test strategies, Test plans, Test cases, Test scripts and Test reports.
• Documented Remediation Plan for systems that were partially compliant or non-compliant with cGMP guidelines.
• Documenting and reviewing validation summary reports.