D E N I S M A C H O K A INTEGRITY-COMMITTED-RESULTS OVERVIEW A Sr. Project Manager and IT Systems Compliance Expert with over 25 years of experience in the Pharmaceutical, Nutraceutical, Cosmeceutical, and Medical Device Industries. Focused on Results, delivering Projects on time and within budget, ensuring employer satisfaction. Experienced in managing various size project teams through the project life cycle. Skilled in managing multi-cultural teams in international locations. Instrumental in developing and maintaining key cross-functional relationships especially with internal and external business partners. Able to effectively communicate with all levels of the company especially senior leadership. Most recently serving as a Sr. Project Manager to IT Quality and as a Leader in Software compliance and Remediation Projects to Fortune 500 Medical Device Manufacturing Clinical and Pharmaceutical Companies. PROFESSIONAL SUMMARY PROJECT MANAGEMENT Currently, leading 6 major global projects involved in the implementation of eQMS capability and clinical implementation of systems. Previously lead a team in development of a global IT quality compliance system and qualification and validation over 180 GxP relevant systems. 2 years ago, implemented an integrated global software quality system that involved Software development, software testing, systems transfer and deployment to 3 international sites globally, Instrumental in set up, configuration and validation of an International Offshore Delivery Center for the VISIONAIRE® 3D Patient Match Technology in Noida, India, Aarau, Switzerland and Sidney, Australia while leading legacy software remediation of the entire division comprised of over 300 GxP applications. Experienced in effective global multicultural project planning. In projects, able to design a team and recruit good talent for tasks identified. As a project lead, able to provide consistent direction to project teams using product-based planning techniques to identify the critical path with key deliverables and dependencies. Possess creative problem-solving skills that allow for development and maintenance of key cross-functional relationships both internally and externally. Obsessed with developing, tracking and reporting project metrics. A strong Advocate of consistency, change management, and a SYSTEMS COMPLIANCE AND VALIDATION SERVICES LLC INTEGRITY. COMMITTED . RESULTS
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D E N I S M A C H O K A
INTEGRITY-COMMITTED-RESULTS
OVERVIEW
A Sr. Project Manager and IT Systems Compliance Expert with over 25 years of experience in the Pharmaceutical, Nutraceutical, Cosmeceutical, and Medical Device Industries. Focused on Results, delivering Projects on time and within budget, ensuring employer satisfaction. Experienced in managing various size project teams through the project life cycle. Skilled in managing multi-cultural teams in international locations. Instrumental in developing and maintaining key cross-functional relationships especially with internal and external business partners. Able to effectively communicate with all levels of the company especially senior leadership. Most recently serving as a Sr. Project Manager to IT Quality and as a Leader in Software compliance and Remediation Projects to Fortune 500 Medical Device Manufacturing Clinical and Pharmaceutical Companies.
PROFESSIONAL SUMMARY
PROJECT MANAGEMENTCurrently, leading 6 major global projects involved in the implementation of eQMS capability and clinical implementation of systems. Previously lead a team in development of a global IT quality compliance system and qualification and validation over 180 GxP relevant systems. 2 years ago, implemented an integrated global software quality system that involved Software development, software testing, systems transfer and deployment to 3 international sites globally, Instrumental in set up, configuration and validation of an International Offshore Delivery Center for the VISIONAIRE® 3D Patient Match Technology in Noida, India, Aarau, Switzerland and Sidney, Australia while leading legacy software remediation of the entire division comprised of over 300 GxP applications. Experienced in effective global multicultural project planning. In projects, able to design a team and recruit good talent for tasks identified. As a project lead, able to provide consistent direction to project teams using product-based planning techniques to identify the critical path with key deliverables and dependencies. Possess creative problem-solving skills that allow for development and maintenance of key cross-functional relationships both internally and externally. Obsessed with developing, tracking and reporting project metrics. A strong Advocate of consistency, change management, and a team’s focus on the critical few with largest impact. An innate ability to focus on the “Big Picture” without losing site of the details.
MEDICAL DEVICE STERILIZATION/CLEANING EXPERIENCEExpert in the application of FDA/ISO regulations related to Medical Device Cleaning and Sterilization. Developed documents related to cleaning policy, SOP development, cleaning process validation, developed sterilization validation deliverables such as risk assessment and IQ/OQ/PQ. Completed projects involving clean room and sterilization the projects were at Abraxis (Isolators, laboratory, clean room validation, at Boston Scientific and Shire Pharmaceuticals developed and reviewed documents related to validation of autoclaves, ovens and dishwashers.
S Y S T E M S C O M P L I A N C E A N D V A L I D A T I O N S E R V I C E S L L CINTEGRITY . COMMITTED . RESULTS
COMPUTER SYSTEMS COMPLIANCE ASSESSMENT & ANALYSISConducted Part 11 Risk Assessments on over 280 software systems worldwide assigning a risk category of high, medium, or low based on system’s intended use. Determined GxP applicability and identified applicable predicate rule. Authored Compliance Assessments and Corrective Action Plans for all high-risk systems and key medium and low-risk pharmaceutical systems ranging from lab equipment, such as HPLCs and Spectrophotometers to Digital Control Systems for manufacturing plants, Building Management Systems, Stability Chambers and Purified Water Systems. Conducted detailed interview sessions with Business Managers, Analysts System Owners, and Expert Users for computerized systems. Advised client system owners on 21 CFR Part 11 applicability and remediation options. Facilitated acceptance of assessment findings.
SOFTWARE QUALITY AUDITORCreated a system for auditing computer systems vendors. Implemented this by drafting SOP’s, Audit and questionnaire templates and report templates. Identified business requirements unique to software classification based on Risk. Standardized audit procedures though 3 sites. Based on User Requirements conducted several successful Software/computer Audits. Specifically, created detailed Audit checklists, Audit plan and upon completion of Audits, Compiled Audit Reports. Reviewed findings, addressed concerns to Senior Management and Conducted follow up meetings that addressed implications of audits and vendor commitments.
VALIDATION EXPERTExperienced in Laboratory Method Validations, Process Validations, Cleaning validations, Building Automations Systems, Microbiology Laboratory Validations, Facility Commissioning, Legacy Equipment Validations etc. Successfully performed over 200 different Software and Equipment Validations, reviewed validation protocols from consultants, vendors and internal resources. Managed a validation effort across multiple sites in the US and Canada. Experienced in the application GAMP methodologies.
LABORATORY EQUIPMENT VALIDATION PRODUCT TESTING EXPERTAs a Chemist experienced in Validation/ Remediation/Qualification of Analytical Software systems, Equipment and Methods to meet USP standards, implemented new cleaning programs, developed a cleaning matrix, reviewed cleaning and validation documents, Expanded laboratory activities to include the purchase and validation of new microbiology laboratory and validated the Biolog, furnace/Autoclaves and Isolators. Developed analytical methods for EPA, NPDES (Testing Methodologies for National Pollutants). As part of an elite team from Oklahoma State University, developed a sensing algorithm method used by TSA in Airports.
REGULATORY AFFAIRS REPRESENTATIVEExperienced filing 510(k)’s/PMAs/IDEs/ NDA and ANDA submissions. Interacted with the FDA representatives in audit. Responded to FDA’s 483 issuance. Lead implementation of new Quality System that included overhaul of the Change Control System, CAPA, Complaints, Product Testing and Product Release Cycle, Regulatory Compliance, Internal Auditing etc. Re-created new Quality plans, MBR (Master Batch Record) Template and quality documents used in manufacturing. Expert at applying GLP, cGMP, GXP, ICH, ASHRAE,ISO,WHO and HIPAA laws. Developed procedures for DEA’s regulations involving FDA’s CFR 1300 for schedule 1 and 2 drugs. Experienced in the practical application of the FDA regulations-both the "letter of the law" and their implied requirements. Experienced at performing Software Quality Audits for both ISO 9001:2000, BS EN 62304-2006 and 13485.
DENIS MACHOKA, Page 3 [email protected] documents for regulated systems for compliance. Previously has served as a remote Quality Assurance Reviewer for Pharmaceutical and Medical Device companies. Projects documents reviewed have included those related to Legacy Remediation of pharmaceutical equipment and automated systems; the implementation of new liquid filling lines. Reviewed multiple project validation documentation packages for technical accuracy, adherence to Good Documentation Practices (GDP), corporate SOPs, and regulatory compliance (21 CFR Parts 11, 210, 211, 62304 and 820). Served as document approver to Validation Consultants and Sr. Staff.
BUSINESS ANALYST (BA)Apply business analytical skills developing software requirements for development, improvement and upgrades of applications.
PH # 515-339-6199INTEGRITY . COMMITTED . RESULTS
EXPERIENCE
July 2014 – Current Mylan Pharmaceuticals/ Carnegie Mellon – IT Quality Pittsburg, PAGlobal IT Sr. Project Manager (IT Quality Systems)
Leading 6 Tier 1 company “must have” global projects for 2014-2015 involved in delivering eQMS capability and as part of IDMP Compliance working to implement proprietary clinical research system, IXRS and EDC enhancements affecting over 44 Global sites throughout the world after acquisitions. Projects involve deployment, migration, implementation and validation.
July 2014 – October 2014 HeartWare Inc. – Manufacturing Systems Miami Lakes, FLValidation Consultant (Remote)
Developing Validation scripts for the implementation of Camstar MES System.
July 2014 – August 2014 NewLink Genetics. – Laboratory Systems Ames, IASr. Validation Specialist (Remote)
Helped validate and qualified laboratory software systems involved in stage 3 genetic systems research.
July 2014 – October 2014 CytRx Corporation. – IT Quality Los Angeles, CALead IT Systems Auditor (Sr. CSV Auditor)
Leading a global audit of clinical systems globally. Scheduled to travel to Nottingham-UK, Berlin-Germany and Hyderabad-India.
June 2013 – June 2014 Lorillard Inc. / RJ Reynolds– IT Quality Greensboro, NCSr. IT Systems Compliance & Regulatory Specialist (IT Quality Systems)
Lead a team in development of an integrated Global IT Quality System and Validation. Set company strategy for IT compliance to FDA regulations. Managing Project with resources performing validation of critical Systems such as Data Clinical Systems, InterSpec, LIMS,DMS, CAT (Change Control System), Lot Tracking, HPQC, Team Track ,Share Point, SAP etc. a total of over 180 GxP relevant systems and a total of 357 Software applications related to IT.
February 2013 – July 2013 Terumo Cardiovascular Systems Corp. – Software Quality Ann Arbor, MISr. Consultant Validation (Software Remediation)
As part of the Consent Decree Team, participated in setting strategy for testing, data migration, infrastructure qualification, risk assessment, documentation of business process work flows as part of remediation of over 90 GxP programs of customized JDE/SAP World One System as part of Software Remediation Team while preparing site for Quintiles and FDA Site Recertification.
As part of the leadership team, led team in execution of FRS, OQs & PQs for 90 programs used in JD Edwards ERP System.
Performed a GAP Analysis in order to be compliant with 21 CFR Part 11, Security and Data Integrity requirements.
Worked with the IT team to remediate the GAPs identified after assessment was completed.
Developed Corrective and Preventive Action Plans(CAPAs) to remediate the FDA audit findings in their inspection.
Reviewed, developed updated procedures (SOPs) as required for the JDE system for the system.
February 2011 – November 2012 BioVentus/Smith & Nephew Inc. – Software Quality RTP/Memphis , TNMgr. Software Validation (Advanced Surgical Devices Division-ASDD)
Provided global multiple project leadership and created an Integrated Global Quality Software System with a team of software engineers that include leading the remediation of legacy and validation existing software. Provided expertise and technical guidance regarding all aspects of software applications for medical products, manufacturing systems, and software validation. Guided all global locations in the validation of manufacturing systems, web based applications, and medical device software. Interacted with all levels of management to communicate software validation requirements and project schedules. Performed Audits of software applications and systems, developed software validation specifications, Software Validation Master Plans and Established controls within the software lifecycle system. Represented global software validation team in internal and external audits.
September 2009 – February 2011 Boston Scientific Corp – Software Quality Spencer , INSr. Software Quality Engineer (SQAE)
Provided QA support for software changes, validation and remediation efforts for over 200 Computer Systems at the Spencer site and led the Legacy Software Remediation team. Reviewed documentation related to all changes, Validations, Revalidations and Analyzed existing Corporate Computer Systems for applicability to site, determined Software Quality Risk based on Intended Use and recommend actions based on internal and corporate procedures. Team included 10 Software Validation Engineers, 1 Equipment Tech and 1 Co-Op.Other responsibilities included:.
Developed software system integrations, validations and remediation strategies for BSC Global
Reviewed and approved all Spencer Site Quality System Software updates, upgrades, patches and software changes
Represented QA in new software implementation, upgrades and validation projects Served as site Sr. Software Quality Systems Advisor to Sr. Management in Software
Review Boards Co-ordinated and review software remediation and retirement documents on site.
Train junior engineers on Software Validation requirements Performed system administration role for DaCs software system Reviewed validation deliverables for tools such as Excel, data queries used in
Management Reviews Standardized the intent and application of change management systems such as
PCAF, QMAC and DCAF validation standards within BSCI. Reviewed protocols and documents related to Legacy software retirements.
Reviewed and approved documents such as : Intended Use, Software System Assessment, Part 11 ERES assessments, Validation Plan, Remediation plans, Software Design Requirements, test plans, Traceability Matrix, Test Protocols with results and Validation Reports
Sr. Quality Engineer MES (Manufacturing Execution System)Provided eMfg QA Support for implementation of MES to 23 Manufacturing Lines at Spencer facility starting with the Interject Line. Improved processes by integrating MES/SAP into Spencer site and the Global Quality System. Developed and updated documentation for the control of activities involving MES within the site. Conferred with senior management on issues that had impact on the MES System and the existing quality system.
Other responsibilities include:. Represented Spencer site interests to the Global MES Team Served as site MES Quality Assurance Advisor to Sr. Management Identified and update Site SOP’s affected with Change. Created, reviewed, and approved MES-related change requests related to workflows
and product instances Co-ordinated MES upgrades, Business Simulation and Cut-Over Activities related to
line upgrades to MES Performed process improvements within site and MES application functionality
Systems: Camstar- Insight application, Windchill 9.1 Product Development Data Repository, DaCs, SAP.
September 2008 – January 2009 Shire Pharmaceuticals– Quality Owings Mills, MDQA Validation Manager
Led a team of 4 in the remediation of over 114 legacy manufacturing equipment and revalidation initiative for entire facility. Participated in the development and execution of cleaning validation. Approved and reviewed all high risk equipment validation protocols and cleaning validation documents
Responsibilities included: Led projects that involved all equipment risk assessment and then recommended
approaches to revalidation of a solid dosage facility manufacturing equipments. Reviewed completeness of the validation efforts of existing systems Expert in clean rooms, environmental monitoring, facility design, building
commissioning, HVAC etc Developed and executed master cleaning plans for multi-product parenteral facilities
and solid dosage manufacturing facilities. Assisted in the development of cleaning processes and validation of sampling
procedures (Swab identification, Matrix creation) and evaluated suitability of Lab Analytical Methods.
January 2007– September 2008PharmaSys Inc - Computer Validation Cary, NC
Project Manager and Sr. ConsultantPerformed various Computer Systems Validation for several companies
Stiefel Laboratories (GSK) Oak Hill, NYValidated entire building structure of Stiefel’s manufacturing facility including the BMS system
Reviewed and audited documents by previous consultants
Leiner Health Products (Nature’s Bounty) Wilson, NCPerformed Validation of several QC Analytical Systems starting with Waters Empower Systems, as QC SME (Subject Matter Expert) Performed investigations on released product data that included data mining from IT systems to verify questionable analytical data of results to the FDA. Performed 21 CFR Part 11 System Assessments for over 300 GxP systems and ranked them in order of priority for the company. Performed validation of their SAP systems through 3 sites.
Leiner Health Products (Nature’s Bounty) Fort Mill, SCAs part of FDA commitments, performed Electronic Batch Record reviews and laboratory data integrity mitigations. Updated SOP’s
Leiner Health Products (Nature’s Bounty) Garden Grove CAAudited Validation methods for an entire company and authored Validation Method Gaps Reports
Leiner Health Products (Nature’s Bounty) Carson CAConducted Software & Quality Audits for both ISO 9001:2000 and 13485, Performed computer system and component risk assessments Performed training and acted as a remote administrator for their client server system
The Henry Jackson Foundation of Military Medicine (HJFMM) Gaithersburg MDValidated their proprietary Clinical Data Software and Trackwise software for handling their clinical trial information
Responsibilities included:o Developed and expanded business to the Midwest and west coast regionso Ensured correct number of consultant resources were hired for various projectso Communicated and negotiated contracts for consultants and contractual
extensionso Managed project deliverableso Coordinated the contractual agreementso Reviewed validation protocols, master plans, projections and approacheso Acted as a remote administrator to their client server system
September 2006 – January 2007 Omni Care Toledo, OHSr. Consultant
Assisted the company design quality management system for the development or manufacture of medical products that met the design control regulations of 21 CFR 820.30 or EN 46001 and the GMP requirements of 21 CFR 211, 606, 820. These systems would facilitate design control, validation, change management (unexpected and planned change), and documentation. Developed SOP’s for the control and testing for the lidding systems
January 2006 – September 2006 Sun Pharmaceuticals Industries Ltd
Wrote a response letter to FDA’s 483 observations, completed a mega interdepartmental project to implement corrective actions to the FDA observations. Implemented laboratory automation, software qualification and paperless initiativesExperienced with the United States, Arab, Canadian and European Community guidelines which reference to ISO requirements for medical devices and medicinal products, Served as a training manager for the company for the following business units: compliance services, automation integration, IT solutions, and software development, Developed and maintained corporate QMS for products and services across all business units of the organization, Implemented industry standards in SDLC for product development, Provided Oversight and management of web-based change control / product issue resolution system. Developed procedures for DEA’s regulations involving FDA’s CFR 1300 for schedule 1 and 2 drugs
January 2005 – January 2006 Qualis Inc Des Moines, IAQA/QC Laboratory Manager
Proficient in USP-NF Product Testing Methodologies for Solid and Liquid Dosages. Led a project to upgrade analytical methods for a company to claim “tested per USP”. Developed analytical methods for EPA, NPDES (Testing Methodologies for National Pollutants). Expert in HPLC equipment validation, troubleshoot, and repair Hired over 20 new chemists in response to added laboratory load Completed the purchase and qualification of Stability Chambers, GC’s, LC’s and misc Lab equipment. Designed validation protocols for the validation and continued monitoring of systems used to generate "purified water" including carbon filters, water softeners, reverse osmosis (RO) systems, deionized water (DI) systems, and ultra-filtration systems. Designed validation protocols for the validation and continued monitoring of systems used to generate water for injection (WFI) and pure steam. The scale and complexity of these systems ranged from laboratory scale to large manufacturing plant systems with a multiple effect still, several storage tanks, and multiple recirculating loops. Performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes.
January 2004 – November 2004 Cardinal Health PTS Fort Worth, TXQA/QC Laboratory Supervisor
As QA/QC supervisor lead a team of 40 analysts in the analysis and release of solid dosage products at Cardinal Health Products. Responsibilities included: Managing the release and testing of Raw Materials and finished products. Initiated and completed Non conformances, reviewed analysts data, Trained new users in the use of the client server system, Fixed and maintained laboratory systemsValidated HPLC’s
January 2004 - July 2004 Nomadics, Inc. Stillwater, OKAssociate Engineer
As a Research Engineer developed sensors and improved analytical methods for the testing of materials for the Dept of transportation and TSA as part of Airport Screening Sensory technologies
January 2002 – February 2004 ConocoPhillips Petroleum Company Ponca City, OK
Sr. Research ScientistAs part of a ConocoPhillips analytical team participated in a breakthrough research in identification of naphthenic acids and solution to corrosion, Managed 3 Laboratories and 5 technicians that included the wet chemistry Lab, GPC lab and the HPLC Laboratory, acted as lead for coordinating the testing and performing select tests for research and patent infringement investigations, Developed several technical reports based on continuous analysis of products that was used in winning a number of cases relating to patent infringements
1st Quarter’01 and March 2009-April 2009Analytical Chemist Abraxis Biosciences Melrose Park, IL
Tested all incoming and finished products in their chemistry lab and recently created the validation documents for the commissioning of the new Micro Laboratory. These included documents for the clean room, fume hoods and validation of Isolators
EDUCATIONUndergraduate Degrees B.A., Chemistry, Lewis University, Romeoville, IL 2001 B.S., Biology, Lewis University, Romeoville, IL 2001 National Deans List 2000 & 2001
Graduate Courses M.S., Engineering Technology Management (MSET) Oklahoma State University Stwtr OK M.S., Information Systems(IS) Strayer University (Current) VA
4.0 GPA Online
M.S., Jurisprudence (Pharmaceutical & Medical Device Law) Seton Hall University (Jan 11,2015)
Certificate Pursued M. S., Software Engineering West Virginia University, Mrgntwn, WV
Certificates EarnedWaters® NuGenesis SDMS Version 6.0.1 Administrator - Waters Corp.Advanced HPLC Method Development - Rheodyne/LC ResourcesGel Permeation Chromatography (GPC) - Theory & Practice - Waters Corp.Advanced Millennium V4.0 - Waters Corp.Empower Software - Waters Corp.
PROFESSIONAL PUBLICATIONS, MEMBERSHIPS & TRAINING
Former Member ISPE –Great Lakes Chapter.Member ASQ, NSBE (National Society of Black Engineers) Research Triangle Alumni ChapterResearch: Recognition Effects of Napthenic Acids in Petroleum ConocoPhillips Petroleum, Ponca City, OKWorkshop: Careers in Validation (Lewis University) Romeoville, IL
Training: GAMP Computerized Systems Validation & Compliance – ISPE, Raleigh, NCTraining: GMP Certificate - Sun Pharmaceuticals Industries,
Bryan, OH.Publication: Author Global Project Planning- The Human Factors
ATHLETIC ACHIEVEMENTS
1999 NCAA Track and Field Champion 1998 Great Lakes Region Conf. Champion1998 Lewis & NEIU School Track Records 1998 Drake Relays Champion1999 Chicagoland Champion 1996 World Intervarsity Games Championships
DETAILED TECHNICAL SUMMARYEXPERIENCE IN MANUFACTURING EQUIPMENT VALIDATIONS: Authored, Executed, Lead, Managed, and Reported on complete life cycle of system Validation deliverables DEPYROGENATION OVENS
o Despatch depyrogenation ovens, Gehnrich UTILITY SYSTEMS
o Clean Steam, o Emergency Power Generators, o Compressed Gases, o DI Water, o Plant Steam, o Water-For-Injection (WFI), o USP Water, o AHUs (Air Handling Units)
SOFTWARE: Experienced in SDLC methodologies such as: ANSI, AAMI, GAMP, IEEE, ISA, BS EN IEC and
ISO. Balanced experience across embedded, standalone, and distributed systems. Experience in development (modest ladder logic / SFC programming / VB and SQL
experience), Design Review, FAT, SAT (Commissioning and Qualification), Validation, On-Going Maintenance / Change and Configuration Management.
ENTERPRISE SOFTWARE VALIDATION EXPERIENCEo ProcessPro, o Excel o ERP-Pro, o SAPo JD Edwards (Citrix), World oneo BPCS.o Qumas/Documentum -Electronic Document Management System (EDMS) with corporate
scopeo Pilgrim,o DataStream 7i
Oracle Database in a client/Server environment DCS/MES
COMPUTER SYSTEMS VALIDATION EXPERIENCE: Authored, Executed, Lead, Managed, and Reported on complete life cycle of system
Validation deliverables for all 5 GAMP categories of systems. COTS Software
o Unigraphics NX 7.5o Bugzillao Subversiono Geomagic
Client-Server (DB) based Systemso VISIONAIRE® - Proprietary SN 3D Design Softwareo Millennium32 V 4.0 , Empower I and IIo PLims 2000, o Sparta Trackwiseo LabWare LIMS, o SQL*LIMSo JD Edwards, SAPo BPCSo VB/HTML/SQL-based Manufacturing Data Management System (MDMS)o Bespoke/Custom Oracle database application to track product complaints, adverse
event reportingo E-Flexion Automated Data Management Systemo PAT toolkit (VB, .NET, SQL)o OSI PI
Standalone PC-based Systemso MS Access database programs including a system to track controlled substanceso Specialty Measurements International (SMI) data acquisition systemso MS Excel Spreadsheets
