SAMSON A competent, goal-oriented, energetic, self starter professional with over twent y years (20-yrs) of QA / IT/ IS Technical Project

Lead and Management experience in Global Foods, Drugs, Medical Devices and Software (including embedded Softwa re), Manufacturing Businesses, All Validations, Quality Assurance Systems Regula tory Operations, Production, Clinical and R&D Laboratory (Test Methods) Processe s, Regulatory Affairs (International and Global CMC Submissions) & Compliance (5 10k, 505(b)(1), 505(b)(2) and 505j submissions SME). Including (but not limited to) ERP (SAP) Development & Implementation, Business re-engineering and integrat ion, Validations (Software, Computer Systems, Utilities, LIMS, Equipment, CIP/ S IP Cleaning Processes, Manufacturing Processes and Medical Devices) in Manufactu ring, Pharmaceutical, Biotechnology and Foods Manufacturing Environment. I have solid 10 yrs IT / IS experience with three full SAP Developments & Implem entations as a technical lead and trainer in the following modules: ECC 6.0 MM / PP/ PM / QM, FI-CO / SD /BW & BI I have solid 20 years of experience in Global QA, QC, All Validations (including Computerized Systems) & Regulatory Compliance in FDA regulated environment in p roduct productions and operations. GLOBAL REGULATORY AFFAIRS & COMPLIANCE EXPERTISE * 21 CFR Part 820 Medical Device Regulations * FDA, ISO Audit & NSAI * 21 CFR Parts 11, 117, 210 & 211, 250, 501 * GAMP5, CGMP, ICH Q7A, SOX, HIPPA * EU, MHRA, International & Global Regulations * Submissions / Approval- facilitator (510K) International Experience* Global C MC * cGMP Process Assessments and Gap Analysis * ASP-SOP, CAPA, NCR , MBR,DMF, DHF, IIR & SCC * CAPA tools Six Sigma/Sys: OASI S/ Net Regulus & Access * ISO 13485:2003 and ISO 14971 (risk management). * QA Sys, IT/IS ERP Dev & Implementation / Training * Food, Drug & Medical Device, Auditor; Regulatory Affairs & Compliance includin g Safety and Validation TECHNICAL SKILLS * Software / All ERP -SDLC-Developer, Implementation and Integration Analysis-JD Edward, LIMS, Oracle & SAP* SME in SQL, ABAP, JAVA, ORACLE & VB * VALIDATION / CHANGE CONTROL & CAPA: Software / Process Automation / Medical Devices Embedded Software/LIMS (Labware) , SDLC including All ERP & ALL SAP modules * VALIDATION / CHANGE CONTROL & CAPA: Cleaning-CIP / SIP, Manufacturing Process &Process Automation / MES / Packaging & Labeling Software / Utility, Systems, Process and Equipment, Protein Purificat ion, Solid Dosage Processing Aseptic Processing - SVP Operations / Microbiology & Environmental Monitoring, and Biotech - Cell Culture Process

Professional Experience Jan 2011 to Present: HeartWare (Miami, Florida) Global IT / IS / QC / QA / Medical Device Operations / Validation & Regulatory C

ompliance SME * Remediation SME: Review the observation found in the Medical Device Coating Pr ocess, Manufacturing Assembly Cleaning Process and Soldering of assembly compon ents Process * Audit Coating & other contracting vendors and bring them to compliance * Answer the observation and make soud recommendation moving forward and get the company ready for FDA Audit Feb 2010 to Dec2010: Hospira (Lake Forest, Illinois) Global IT / IS / QC / QA / Operations / Validation & Regulatory Compliance SME * Global Data integration & Validation SME: SAP / TrakWise implementation and in tegration-Microsoft Suites tool -Test script review-Multiple Data Migration. Pro vide technical in All SAP modules, IDOCS and quality solutions. Working directly with the VP of Corporate Quality and IT / Operations / IT Validation Lead * Design Control SME, working directly with Corporate Snr Engineering Manager to facilitate Change Management program Update * CAPA program manager-Working directly with Corporate CAPA lead to close outsta nding Exception Reports and Monitoring effectiveness of the outstanding CAPAs * Issue Elevation Technical Expert / working directly with VP of Corporate Quali ty/Operations, VP of Quality / R&D, Director of Global Product Safety, VP of Reg ulatory , VP of Commercial Tech-Ups and VP of Compliance -to address product fie ld complaints that have been elevated to the upper management, that requires imm ediate interventions for immediate remediation recommendation action..i.e Recall or Further investigation or requiring design change control. Review 510K and 50 5 including clinical Data / CMC validation and manufacturing Data and process va lidation * Conduct a review and risk assessment outstanding investigation and corrective actions to insure that changes and justifications meet all quality and regulator y compliance Nov 2009 to Feb 2010: Hospira (McPherson, Kansas) Drug Manufacturing Process and Cleaning Validation SME * Review the entire process including cleaning validation, remediation, Risk ana lysis, and write the PQR and the PVR for the entire process for the previous qua lifications for four different Filling lines process (for Momento, Eli Lily and GSK) : Media Fill, Hold Time, Mix Time and Fill Uniformity, Filtration, Filling Line CIP and SIP Cleaning, Tank Cleaning. Help establish Golding template for th e VMP, PVP, PQP, PRQ and PVR for future Validation. * Revamping the Quality System of the entire Drug Manufacturing Process at the s ite Sept 2007 to Sep 2009: PepsiCo (Chicago) SAP Lead Technical IS/T -R&D and QA Business Integration NPI & SAP 1-UP & Projec t Manager (SME) As SME: Supervise Developers and Analysts- Represented End Users -All R&D/ Suppl y Chain Business units, Review the ABAP codes/ Configurations / UR & FR document ation including Test Scripts, flush out gaps, make changes through change contro ls. * Managed R&D Global SAP implementation & Integrated Program (including Multiple Data Migration) planning and coordination across all teams and Business Units i ncluding stake holders. * Responsible for ALL implementations & Integration Architecture solution and D esign integration blue Print for over-all complex PepsiCo (6) business units sys tem integrations * Developed / maintained and Utilized MS Project to track project status: for Pe

riodic Status report to the sponsor(s), to guide the team through the project ti meline and deliverables. * Utilizing Web Services, SOA/Middleware, data transformation and integration to ols such as Informatica ETL SAP PI, Tibco, JIRA, Scibe and BizTalk * As R&D and Supply Chain PM, engaged with Offshore SAP developer to ensure all R&D & SCM requirements were properly and successfully implemented in SAP. * Represented and collaborated with all PepsiCo Business Units to map out draft of business re-engineering and integration requirement document for the future s tate of the SAP. * Managed, analyze and mapped out the following Business processes opportunities management in CRM such as: order management, Subscription, Transportation, Ware house and Distribution Management. And utilizing Salesforce.com Web Services API to interface with contracting companies, customers and distributors * Provided leadership in SAP: Events Management, User Requirements, Functional R equirements, QA Review & Execution of Test Scripts -FI/CO, IDOCs, CO-PA, HR, SD, EM, ECC 6.0, MMD, PMD, PP, PM, QP, BW ,CRM & New Product Introduction (NPI), AP I - Perform in-depth analysis of current SAP_NPI, flush out GAPS and implement C APA / NCR handling, GAP analysis to drive execution of the gaps by Six Sigma DMA IC method & DFSS, SOX compliance * Create training manual of as is SAP ECC-MMD SCD/WMS/CRM/ MM, PMD, BOM, FI/CO, COPA, CO, MP and PP process flows and End state process flow recommendation. * Tools included: ABAP, MES, OPC HIM SDACA, POMS-specifications, DCOM, PL / SQL Jan 2007 to Sept 2007: Novartis (California) Validation & Quality Assurance Project Manager, Lead Engineer Consultant (SME) * Review previous IQ for hardware/software and specify updates required. Help i n review and edits of SDS, SCS and SRS for the development of the LIMS LabWare a nd SAP_ LIMS LabWare. Integration ETL. JIRA * Tracking tool (Main hands on Tasks: Provide Technical Configuration and Functi onal guidance to the developer. Qualifications to monitor product and customer's satisfaction. * Review Blue Prints and Configuration to ensure Client's requirements are full y leveraged in the LIMS LabWare and SAP _ LIMS Integration Work Flow. * Review Test cases prior to and after execution to ensure robustness of the in tegration and hence ensure client's requirement are leveraged) Create IQ test p lan for DBs: window 2003, Citrx and Oracle 10 installation, label printers, repo rt printers, barcode scanners and LIMS LabWare software. * Perform IQ for test and production environments Write IQ report for test and production environments. Create OQ and PQ test plan for LIMS Environmental Monit oring (EM) and Raw Materials (RM). * Develop data set for OQ and PQ execution. Train users and assist users in exe cuting OQ and PQ. * Write OQ and PQ summary reports EM and RM. Editing/creation of new SOPs for bo th system and laboratory needs Feb 2006 to Jan 2007: Boston Scientific Cooperate (Indiana & Boston) Lead Engineer Consultant (SME) Medical Device Validation & Senior Quality Assura nce, * Project Horizon. Manufacturing Products & Process Remediation, Senior Quality Assurance Validation Engineer, Reviewer, Authors and Executes Protocols Test Ca ses, Requirements Document, TM, TMV, IQP, OQP, PPQ, PV &SV, MVP, GAP Assessments and Reports. Qualifications to monitor product and customer's satisfaction. * Interface very closely with SQE, Manufacturing and R&D Engineering department s. * Utilizing SAP to monitor and track parts from components, sub-assembly to Fin ish Goods management for NSMR. * Very fluent with PDM and Mini-Tab 14 for data analysis, also train Coops on M iniTab utilization.

* Representative of QA, ensuring product realization life cycle quality assuran ce: From product quality planning, device design, R&D, testing, Verification & V alidation, and production support, including implementation of CAPA (and review of CAPA records, Investigations, CA implementation, and verifications. * Qualifications to monitor product and customer's satisfaction. * Ensured product meets CFR 820, ISO 134385 and EU standards * Ensured the product lifecycle process follow QA system that consistently prod uce product that is of high quality and within specifications standard set by QA for the product and documented using the following processes:- DHF TM, TMV-all lab instruments including HPLC, IQP, OQP, PPQ, PV & SV, MVP, GAP Assessments, DC N, CAPA, NCR, PDR and Calibration and Maintenance record. Tools used .NET, MES, PL / SQL Sept 2004 to Feb 2006: Boston Scientific Cooperate (Minnesota & Ireland) Lead Technical Engineer Consultant (SME) Medical Device Senior Quality Assurance * Senior Software/Equipment Validation Consultant (SME) -Responsibility includes : Peer (SQE/Validation) Review of the following (Authoring if possible): SDS, IQ P, OQP, FS, SCS, DRs, and SOPs. * Managed the entire Apex Software; -Design Specifications, Functional and User & requirements Specifications Documentation. * Interface with cross functional group to help facilitate validation of the Ape x System by reviewing and speeding up pre & post-execution approval of the syste m. Interface very closely with SQE and Software/Equipment Engineering department s. Mar 2003 to Sept 2004: Ferro Pfanstiehl Laboratories, Inc. Waukegan IL PM-QA/Regulatory Affairs and Audit SME (Subject Matter Expert) * Company's representative for FDA and Customer's Audit * Conduct a review and risk assessment of the investigation and corrective actio ns to insure that changes and justifications meet all quality and regulatory com pliance * Preparation of APQR, preparation/submission of DMF to Agencies i.e. FDA, Canad a, Euro and others * Review of the following: Deviations, CMC Process/Process validation document, LIMS, Lab instruments TMV including HPLC, Process equipment validation protocols , facility and utility validation documents, Test Methods Protocol, EMS-MES, Pas sivation reports, Calibration records, New code forms, Suppliers assessments/aud it, Customers Audits, Non-conforming Material reports, Documents controls-SOPs-P olicies-Spec's -labels, EM monthly, WFI investigation, EM investigations, stabil ity reports, return products, IIR and CAPA. Jan 2002 to Mar 2003: MRI, Buffalo Grove, IL Lead Quality Auditor/Regulatory Compliance and Validation & CAPA SME * Conducted full-scale audit on the company's manufacturing of medical devices ( Defribulators - including embedded software) operation process/process automatio n. * Performed Gap analysis and assessment, helped generate remediation action plan to address the results of the audit. * Helped designed a cGMP master plan template to address the tasks in order of p riority. * Worked under the QA management direction to helped set up QA plans to ensure t he company is in compliance with the remediation plans. Implemented MBR / DHF (D C) & CAPA / NCR program (review CAPA records, Investigations, review the correct ive action implementation, and its Affectivity), updated the existing Change Con trol, Incident reports and training programs.

Feb 2001 to Jan 2002: Bayer Healthcare, Clayton, NC Lead Integration Technical Engineer Consultant (SME) IT / QA Consultant * Technical Integration Lead and QA review of global computer validation documen ts related to Information, Laboratory and Process Automation Systems comprising check for compliance with global corporate standards, regulatory requirements an d technical expertise. * Main responsibilities are in the area of Information Systems including SAP, La boratory Systems, and Process Automation. PM and Technical lead for SAP (ECC/FICO/CO-PA/MM,HR,QM,BW/BI/CO-PC/AP/AR/GL/AM/OTC etc) integration with all companyw ide IT / IS computer systems) * Initiate and enforce necessary improvements and corrections; attend team meeti ngs pertinent to computer validation. * Implement monitoring and managing validation philosophies and practices to con form to company standards globally and cGMP, while contributing to the overall q uality standards of the company. * Serve as QA adviser for all the Bayer Sites World wide. * Review documents for database and database management systems, analytical syst ems and data acquisition systems. Review equipment and utilities related protoco ls and test method protocols. * Define and communicate (e.g. through SOPs) QA acceptance criteria for Validati on protocols related to computerized systems. * Bring in expertise to other tasks within the QA Validation Department (e.g. * Gap Analysis* Risk Assessments Analysis* Change Control* CAPA). * Supervise and manage QA, IS/IT, and Validation Engineers. Interface with all d ept. heads, FDA and clients on inspections, audits and PIAs. * Strong oral communication and written communication skill, ability to work wit h diverse group of personnel and widely varying technical abilities. * Excellent understanding of the following: Computer Systems Lifecycle, Validati on principles, Client-server architecture and statistical methods. * Experience in system and vendor audits, reviewing, writing and approving requi rements and design documentation) change control process, information and proces s control systems. Sep 2000 to Feb 2001: Aventis Bhearing, Bradley, IL Lead Global Technical IT / Regulatory Compliance SME * As Global Lead Technical / Regulatory Compliance SME, performed QA review of g lobal computer validation documents related to Information and Process Automatio n Systems comprising check for compliance with global corporate standards, regul atory requirements and technical expertise. * Main responsibilities as an efficiency regulatory compliance SME: on Automated Control Systems: Worked with Allen-Bradley PLC 5 / SLC 500 using "RS Logix" rea d -review documents and manipulates PLC's ladder logic code. Data Files: review of data flows from the Recipe (parameters) to the PLC and to ensure it is used in compliance with PLC's. * Review, update and validate company's *iBatch Interface Software with, SCADA, Intellution iFix, Oracle and SAPR/3 4.6-Modules (MM-PP-PM and CO) * Also help training employee on S88 an ISA Standard on Batch Controls. * Gap Analysis, Risk Assessments Analysis, Change Control and Validation in FDA Requirements-OQ: Documentation and Hands-on execution in a FDA environment. * Instrument Test Tools: experience in using portable signal generators to assi st in loop checks and ringing-out control circuits. *Requirements Traceability M atrix (RTM): Developing matrices that link specific technical requirements to sp ecific test results.*Final Reports: experience in writing validation summary re ports, documenting conclusions. March 2000 to Sept 2000: Tyco Healthcare, DeLand, Fl Lead Technical IT / QA Validation Engineer

* Auditing and revalidating of Process, Process Automation and implementation of DHF, CAPA and its effectiveness. * Resolved all of the outstanding NCR issues and ensured all of the outstanding CAPAS were adequately addressed in accordance with CFR compliance. * Trained all IT and Production personnel on CAPA, GxPs, 21 CFR Part 11 and 177, cGAMP, Development, Implementing, Code review on Programs- LabView, Oracle, SAP R/3, Vision System, PLC-Ladder logic using RS-Logix, Emerson Power Tool FM, GLP s, PM / Calibration / Metrology, Documentation and TMV All Lab-Instrumentation ( including HPLC), and Validation (Software Requirements Specification-Life CyclePackage) of all Manufacturing Plant legacy Software. Gap Analysis, Risk Assessme nts Analysis and Change Control & Validation for FDA Requirements. Oct 1999 to Mar 2000: Eli Lilly Pharmaceutical and Co., Indy/Tippecanoe, IN Validation Project Manager * Undertook tasks as Author, Reviewer, Trainer and Project Manager. Supervised B uilding and Utilities, Laboratory, Process/Process Automation Validation, LIMS a nd Computer Software Validation SQ/SRS package: DQ/IQ/OQ/PQ & SE Change Control, P&ID Review, Validation Redesign, Rework, Retest, Review/Rewrite, QC and QA Val idation. Software SAP R/3 4.6, PLCs, DCS, RS3 Fisher Provox, Delta V, ABS/DDC Sy stem (Metasys & HVAC) CIP System. * Included TM Validation of -New Duloxitine-HCL Process/Process Automation- HCL Addition, Temperature Control, DMSO Delivery System, Countermeasures, Heinkle Ce ntrifuge, HPLC, GC-MS, and Delta V DCS. Responsible for the entire SQ-Package. Jul 1998 to Oct 1999: Playtex (Quality Systems Division.), Dover, DE Lead Technical IT / QA Regulatory Compliance SME * Performed QA review of global computer validation documents related to Process and Process Automation Systems comprising check for compliance with global corp orate standards, regulatory requirements and technical expertise. * Also implemented CAPA to review all products complains records (specifically p roduction process). * Trained staff on all QA and Production including the R&D on handling of CAPA a nd NCR * Medical Devices testing Laboratory & Microbiology/Analytical Laboratories; Set -up and training of Laboratory Personnel on LIMS; GxPs, 21 CFR Part 11, GMPs, GL Ps, PM / Calibration / Metrology. * Documentation and Instrumentation, and Validation (SQ-Package) of all Laborato ries and Manufacturing Plant Instruments, Equipment, Utilities including Softwar e:LIMS, Delta V. SOPs, DRQs, PMs/Calibration etc. * Instruments/Equipment included HPLC, GC/MS, Change Control i.e. P&ID Review, T M-Validation Redesign, Rework, Retest, Review/Rewrite Validation. ABS, HVAC, Chi ller Tank/Pump/Tower, CIP Systems, Water system cleaning process and Bacterial m onitor treating process. * Helped put in place gold standard test method template for Process and Process Automation validation. Mar 1996 to Jul 1998: Abbott Diagnostic Division, Abbott Park, IL QA Process & Remediation Lead Engineer * Process, Test Methods, Software Validation Scientist and Trainer: reviewed and rewrote Gold Standard protocols in compliance with FDA standards. * CAPA / NCR implementation and review of old records, Gap Analysis, Risk Assess ments Analysis, Change Control & Validation in FDA Requirements and Systems Qual ification. * Documentation and hands-on execution in a FDA environment. * Training Laboratory Personnel on GxPs, 21 CFR Part 11, GMPs, GLPs, PM / Calibr ation / Metrology, Documentation and Instrumentation, and Validation (SQ-Package ) of all Laboratories and Manufacturing Plant Instruments.

* Utilities included Software, Documentation, Full Validation / Calibration / Me trology and trouble-shooting: controlled release solid dosage forms of drugs, Me dical Devices, Process, Cleaning system, Instrumentation, Piping, Temp Control. * Reviewed, Rewrite, Validation protocols, train and supervise non-validation em ployee. * Full and Upscale Validation of: Cleaning Process of Tanks, All Manufacturing a nd All Lab. Instruments, Utility Systems, HVAC, CIP Systems, Autoclaves, Incubat ors, HPLC, LC/MS, Chromatography Columns/skids Filtration and Immunization syste ms, Process Development, Test Methods, Chemical Synthesis, (intensively retraine d and documented on FDA GxPs OSHA rules and regulations, QA, QC, SOPs, CRA, QSR. * Design of experiments using Statistics JMP/Statistical Programs. * HIV and HCV Probe development (Qualitative & quantitative approach) Research & development Scientist. Methods: Statistics, Elisa, and Sample prep using differ ent columns. PCR Development, Stability Testing and Characterization. * Troubleshooting the reagent both in house and purchased, communication with th e vendors to improve reagents quality, cost effective ways to customize relevant to research needs. * Conjugate/Macro-particles developments. * Heavy PCR work and Immunoassays analyzer method to determine the Probes effect iveness. * Protocol development, intense statistics approach in report preparation. * Writing and reviewing reports. Microbiology, Biochemistry and Molecular Cell B iology knowledge and techniques. Jan 1994 to Mar 1996: UIC, Chicago, IL Clinical Research Scientist/Core lab Manager Clinical Research Center * Managed (6-People) and maintained Core Laboratory to conform to FDA, CLIA and IRB Standard. Documentation, Instrumentation, PM/Calibration and Validation of c ore lab instruments (Gluco-2000 meter, Osmometer, Densitometry, Hematocrit & IMx Instruments) cGLPs, PM. * Reviewed and approved research protocols, coordinated research activities by w orking in parallel with the nurses while executing research, supervised Med. Tec hs. * Reviewed and wrote Grants, coordinated and screened research volunteers (subje cts), data mining and trained MD residence on importance of Clinical Research. * A member of the Scientific Research Advisory Committee. 1988 to Dec 1993: Hoffman-LaRoche Molecular Systems, Piscataway, NJ * Diagnostic research and development of Hepatitis C virus (HCV) Probe (Qualitat ive & quantitative research approach). * Methods: Elisa, Sample prep using different columns. * PCR Development, Stability Testing, Characterization and Statistics Trouble Sh oot the reagent both in house and purchased, communicate with the vendors to imp rove reagents quality, cost effective ways to customize relevant to research nee d. * Conjugate and Macro particles developments. * Heavy PCR development and Immunoassays analyzer to determine the Probes effect iveness. Protocol development, intense statistics approach in report preparation (cGLPs). * Writing and reviewing reports. Microbiology, Biochemistry, Genetics and Molecu lar Cell Biology (RNA, DNA, * Protein and Amino Acids isolation and purification.) and Biochemistry, Microbi ology, and Statistics knowledge and techniques. Education

Finch University of Health and Science/The Chicago Medical School Graduate & Post Graduate Studies in Biochemistry and Physiology (7/94-12/98) Montclair State University School of Graduate Studies Upper Montclair N.J, Chemical Engineering and Biochemistry (5/92-5/94) Upsala College. E.O. NJ (BS) Double Major Chemical Engineering & Computer Science Award of excellence in chemistry at Upsala College in 1992 Training & Certification * Institute of Validation Technology (IVT) Member; Trained in Computer Validatio n. Trainer, Auditor and Protocol (Writing / Reviewing) * QA validation of Medical Devices, Equipment, processes, Pharmaceuticals, clean in place and systems Software * Six Sigma Black Belt holder and trainer Certification * SQE, CQE and Senior Auditor Certification * SAP Certification in ECC- 6.0 MMD, BI, BW, SD, QM, PP, FI/CO Skills Summary QA/ Regulatory Affairs/ Auditor (Audit WF), Author, IS/T Sr. Integration (includ ing Business) SME, Hands on Execution, Reviewer, Trainer, Six Sigma Black Belt Holder / Trainer, Supervisor, Team Leader, P. Manager, SME, Sr. QA/QC Advisor: V alidation Package, Building & Utilities-HVAC-BMS, Medical Devices, Process/Proce ss Automation, Equipment and Instruments including: Software Validation; Code / Protocol Execution & Review (Using R S Logix, Emerson FM Power Tool, LabView- AN I), Allen-Bradley-PLC 5/ SLC/ DCS/ MES / DCOM / DCE-RPC, JIRA, ERP-SAP (all SAPmodules), EMS, IBM DB2/UDB, Microsoft PL / SQL, Informix, Trackwise, OPC sever / Oracle*Vision Systems*HMI- IMS /SCADA- Application with intellution iFix 3.0*D elta V, LIMS / Trainer / Auditor in FDA Requirements/Rules and Regulations, incl uding 21 CFR Part 11 and GxPs in the following areas: * Handling Out-of-Specific ation Results * FCA* GAMP * SOPs *CAPA/ NCR* DHF * cGMP Training Programs * PreApproval Inspections * Auditing Techniques * FDA Inspections * Design Control * Standard Operation Procedures * SQ package:Lab instruments-TMV/ VMP/RTM/DQ/IQ/O Q/PQ * Gap Analysis* Risk Assessments Analysis*Change Control * Documentation * Failure Investigation * CAPA-Corrective Action * Compliant Handling Systems * Stability*ASP* ISA S88 Batch Control Standard in regulated Environment*GLPs * GC Ps * DOE * PMs / Calibrations / Metrology * QA * APQR * QC * QSR * OSHA * I RB * CLIA * CDER / CBER * IND * NDA * ISO-9000 : 2000 * EN-46000 * CE Mark * API * CMC * ICHQ7A . POMS-specifications CAPA Tools: TrackWise / SmartCAPA / OASIS / Netregulus & Access Programming Languages & Tools: MS Windows, '9X, NT, 2000, ME, MS works, Lotus No tes, WordPro, Excel, Access, Power Point, Adobe, Claris, Dream weaver, Webmaster /Design, A+, C/C++, Java, Unix, DB2, LAN, WAN, JTL, MCSE, SAPR/3, Oracle, Inform ix, Red Hat Linux, MS PL / SQL Server, My SQL, IBM DB2s & AS400, Labware Waters Millennium, HTML, New Genesis, Documentum, e-Commerce and Cisco network. Programming Languages & Tools: ABAP Workbench, MS.VB, .NET & VB.NET, Oracle Dev. 2000, Perl, HTML, CGI, PHP4, Java Script, JIRA, MS Project RDBMS: Oracle, Operating Systems: MS Windows 9x, 2000X, Me, Professional, NT, and Informix, OPC Server Networking: TCP/IP, Server Configurations, and MES