Manager Software

RAJESH PAREKH

Lumberton, NJ ***** ********@*******.***

302-***-**** https://www.linkedin.com/in/rajesh-parekh/

QUALITY MANAGER

Accomplished leader with significant GxP experience in manufacturing, validation, quality, auditing, microbiology laboratory, stability and Environmental monitoring. Adept at analytical method development, IT lab system validation and implementation, analytical method validation, method transfer and setup new analytical laboratory. Proven expertise and experience in Pharmaceutical Manufacturing R&D, QC, QA, Lab IT Compliances & IT, followed by broad experience is in quality compliance management, Drug Enforcement Agency (DEA) and project management. Ability to perform yearly performance review of laboratory staff and help them to setup their personal goals for their personal development. Performed client and contract lab audit as well as involved in FDA audit to ensure compliance. Highly involved in quality control laboratory remediation program.

Key contributions:

Electronic documentation implemented and removed paper trail documentation for Electronic Certificate of Analysis, Out Of Specification Investigation, Corrective and Preventive Action (CAPA) and Change Control.

Setup new lab from ground up at multiple places, that includes work with cross function team and vendor from quotation request to place an order to complete system and application software qualification and system validation including documentation like SOPs, protocols and report.

Review lab instruments life cycle and depreciation and set up the budget to purchase new lab instrument on yearly basis. Meeting with vendors for buying new instruments, getting a quotation and generating justification documents for director and VP for budget approval.

Managed 24 X 6 lab operations (Analytical and Microbiology laboratory with Environmental monitoring) with a staff of 32 personnel. Managed $950K budget for lab instrument, chemicals, Instrument implementation, service contracts and validation. Author and review audit report. Managed multi-shift GxP quality control lab.

Implemented enterprise and client-server Waters Empower software in multiple places, involved in review and approval of software qualification documents. Trained user for executing and building custom reports. Authored by IQ/OQ/PQ documents. Coordinated the execution process of IQ/OQ/PQ part validation. Generated deviation documents for test scripts and procedures.

Saved companies money by implementing in-house testing and qualified ideal systems in use. Total savings of $300K

Involved with finance as a key player in Lab budget for purchasing new equipment, designing new lab and Lab operation budget.

Implemented and trained users on DEA guideline as part 21 CFR Part 1300 and in-house SOP for handling control substances reference standards, samples and process performance qualification samples.

Key player in FDA audit, Contract Manufacturer Audit, OOS, OOT, CAPA & Investigation buying any new lab instruments, vendor qualification.

Achieved and implemented method development and testing of API in aerosol spray products.

Implemented Size Excursion Chromatography (SEC), Capillary Electrophoresis systems and Sebia systems for biochemistry assay.

Achieved microbiology productivity target for Endotoxin and sterility testing.

PROFESSIONAL EXPERIENCE

PHARMEDIUM LLC (DIVISION OF AMERISOURCEBERGEN), Dayton, NJ 08054, 09/2018 to 05/2020

Role: QC Operation Manager

Achieved project management goal by providing all deliverables on time of multiple projects. Implemented and achieved project structure, electronic data review and approval of daily generated data in Empower 3. reporting and custom calculation to meet 21 CFR part 11, data integrity. Developed and implemented multiple methods and SOP in MasterControl.

Achieved analytical method development, USP method verification and Process Performance Qualification protocols authoring and execution of multiple small and long chain molecules as well as control substances.

Implemented revised QC daily routine task in QC analytical, Micro and EM to increase productivity in order to achieve KPI as specified in management matrix.

Involved in qualification and the implementation EQMS MasterControl, LIMS, Compliance software, system, etc.

Implemented training program to handled controlled substances as per DEA guideline as per 21 CFR Part 1300.

Achieved lab remediation program to restart QC analytical lab in 3 months due to FDA 483 observation.

Achieved raw material qualification program for 20 molecules in 6 months.

As a Lab Systems Administrator reviewed and approved lab system equipment qualification and software validation documents.

Review and approve CAPA, lab investigation for OOS data. Review and approve analytical method, validation protocols, and reports, method transfer protocols, reports.

Setup leadership training, weekly meeting with immediate reporting personnel for update, daily KPIs for finished product release, Raw Materials, API and Stability samples.

LUITPOLD PHARMACEUTICALS, Shirley, NY 07/2018 to 09/2018

QA Compliance Manager

Involved in the implementation of new laboratory systems like Empower 3, LIMS, Documentum, etc.

Implemented and achieved system policies to meet 21 CFR part 11 requirement for electronic signature and data integrity. Updated report in Empower 3 to meet data integrity requirements.

Involved in lab HPLC, UPLC, and GC system, troubleshooting related to Empower 3.

Achieved multiple SOP revision by performing risk management and gap analysis.

RENAISSANCE PHARMA, Lakewood, NJ 06/2016 – 04/2018

QC/QA Operation Manager

Implemented and achieved electronic data review and approval of Empower 3 data of finished product, stability and API as well as method development. Authored and executed analytical method development and method validation protocol and reports of multiple molecules, EM, Cleaning validation for regulatory agencies and clients.

Implemented and achieved product release on time of finished product, API, stability samples and excipients as per corporate matrix of measuring KPI as well as Quality internal KPIs.

Implemented and achieved testing strategy to support project management and client requirement for documentation, testing and release specification for components, systems and development products.

Hands-on the Trackwise system for generating SOPs, Methods, deviations, change controls and system qualification. Generate query and report for management monthly KPI reports.

Implemented new ICP-MS system as per USP<232> and <233> for elemental impurities for finished products, API, and excipients.

Managed and trained multiple users to handled controlled substances as per DEA guideline as per 21 CFR Part 1300 and involved in monthly audit for control substance reconciliation of standards and samples.

Developed stability study protocol, testing program and handled stability department as per cGMP requirements. Achieved 100% KPIs monthly basis.

Developed custom fields, custom calculations with clients SME. Develop custom reports for Identification, Assay, Impurities and finished product content uniformity assay as per SME requirements. Develop and Execute custom report validation protocol. Develop and execute custom calculations validation protocol.

Recognize MVP of the lab for that individual extraordinary work performance for that specific month.

BAXALTA INC. (Previously Baxter), Lab Systems Administrator, Covington, GA 09/2014 – 06/2016

WEST-WARD PHARMACEUTICALS, Empower 3 Lead Consultants 02/2014 – 04/2014

GENZYME, Lab systems Compliance, Consultant 01/2013 – 06/2013

GILEAD SCIENCES, Empower 2 & 3 Admin Support Consultant 09/2012 – 01/2013

FLEET LABORATORIES, QC/QA Compliance Manager, Lynchburg, VA 09/2008 – 07/2012

Implemented and performed system administration of Waters Empower 3 Enterprise system for HPLC, UPLC, Agilent 7890 GC with headspace autosampler, Beckman Coulter Capillary Electrophoresis, Waters TQD LC-MS, Thermo IC, Cromeleon software for Thermo 1600 Ion Chromatography, 32 Karat application software for Beckman Capillary Electrophoresis, Siemens BN ProSpec Immunonephelometer Systems. Familiar in Protein characterization, Size Excursion Chromatography, Ion Exchange Chromatography, Malvern Spray system for particle size, and FLIR IR Camera systems.

Implemented and performed system administration with application software for following standalone systems.

oSebia Poresis Core software for Hydrasys2Scan system

oAgilent MassHunter and Open Lab ECM software for ICP-MS and GC-MS system

oPerkin Elmer Winlab software for Lamda 45 UV-Vis system

Performed site administrator for SQL LIMS to support more than 300 users for Raw Material, EM, and Water test Modules. Defined Material Specification, Methods, Operation, lot Plan, Specifications, log plan and RM test plan, specifications, and train user

Developed and authored lab systems Validation plan for Empower 3 enterprise system, Validation documents DQ, RA, SCS, IOQ, URS, CS, TM, Gap assessment and Risk assessment.

Executed, updating protocols for custom fields, custom reports for Empower 3 software

Authored, Reviewed SOP, updated SOP, prepared training documents for the user.

Worked on client consent decree lab equipment qualification documentation and system validation to be complied as per 21CFR Part 11 and ICH. As a quality compliance consultant discuss details with client what documents were required for lab system as per GAMP 5 and 21CFR Part 11.

Implemented electronic documentation in MasterControl for OOS/OOT, CAPA, Investigation and change control.

Managed stability study program, that include development of stability study protocol, testing of 3 different conditions. Improved KPIs from 60% to 100% in 4 months and keeping at 100% after that on every month.

Review and approve CAPA, lab investigation for OOS data. Review and approve analytical method, validation protocols, and reports, method transfer protocols, reports. Support 350 lab users for their system issues including software and hardware. Updated and implemented Empower 2 in Waters NuGenesis LMS

ADDITIONAL RELEVANT EXPERIENCE

CHRYSALIS TECHNOLOGIES (DIVISION OF PHILLIP MORRIS), Richmond, VA Lab IT support Consultant

WYETH CONSUMER HEALTH, Richmond, VA Software validation Consultant

FRONTAGE LABORATORIES, INC, Malvern PA, Group Leader

SL PHARMA LABS, INC., Wilmington DE Senior Development Chemist

Block Drug Co., Inc, South Brunswick, NJ Senior Chemist

CIBA-GEIGY CORP., Suffern, NY Associate Scientist

BIOCRAFT LABORATORIES, INC., Fairfield, NJ Lab Supervisor

Performed and trained testing of API assay on medical device suspension and aerosol spray products. Performed and trained analysts on method development and method transfer activity. Trained on using compliance software Empower 2.

SOFTWARE TOOLS

Microsoft Office Suite Applications (Word, Excel, PowerPoint, Access, Outlook, Project, OneNote, and Visio), National Instrument LabView, Waters Millennium 4.1, Waters Empower, Empower 2 and Empower 3, Waters MassLynx 4.1, Agilent ChemStation for HPLC and GC-MS, Agilent ChemStore, Agilent MassHunter with OpenLab ECM for ICP-MS, PE WinLab, PE TotalChrome, CAMAG WinCAT, JOEL Scanning Electron Microscope, Inca and Agilent MSD Productivity ChemStation. ThermaCAM Research Pro 2.8 and RTool software for FLIR systems. Carl Zeiss software for an optical microscope, Micron software for Fisher-Micron Microscope. Ghost V 8.0, Rheowin, KRUSS Labdesk, Zetasizer PCS DTS v1.61, Agilent UV-Vis, Bart PE. Statistica, Sigma plot, Solidworks, Cispro, ESS complains Suite. Chromeleon for Dionex 1600 IC system, 32Karat for Beckman Capillary Electrophoresis, Phoresis for Sebia Hydrasys2scan gel electrophoresis system, SQL LIMS, Trackwise, and Documentum, MasterControl, Compliance wire, Crystal report and BPIX. EQMS (Enterprise Quality Management system), Live link. BPLM, ISO Train, Minitab statistical software.

EDUCATION

Master’s Degree in Organic Chemistry, South Gujarat University, India

Diploma Computer Programming, Radiant System, Iselin, NJ

PROFESSIONAL CERTIFICATION

Labware LIMS certified (Admin. & Consultant) – 2007,

Empower System Administrator certificate from Waters - 2015

Advance OpenLab ECM system administrator certification from Agilent - 2015

TRAINING

cGMP training (ISPE) - Dec. 2005, August 2011, Management training, Team Building training

Minitab 7 February 2015, Crystal Report 2008 April 2015, SQL LIMS

Agilent MassHunter system administration

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