Cezar Lucki Email & Phone Number

Irvine, CA, US

Long Beach, California, US

• ERP / Enterprise System Validations & Project Management (Class 1 and 2 medical devices):
• Author validation master plan (VMP), risk assessments RA/FMEA, validation plan/protocols (VP), user requirements specifications (URS), functional requirement specs (FRS/SRS), design specs (DS), UAT's with test cases.
• Developing all (above) SDLC deliverables for retrospective SAP Business One Professional (SBO) and prospective SaaS (web based) Master Control and SBO validations.
• Author Work Instructions / SOP's and Admin SOP's for SBO and Backup & Archive systems/process.
• Coordinate with other departments to complete validation tasks.
• Support resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements.

Providing validation support to various VPI clients.

• Authoring & Executing CSV SDLC docs (Req's, VP, VMP, IOQ, PQ, V&V, TM, VSR) Facility, Utility, Lab Systems, IT infrastructure, Equipment, Process, Test Method, and Cleaning Validation Protocols / IQ, OQ (UAT), PQ for.
• Performing audits, gap assessments, reports, and resulting remediation plans, resulting from observations during internal/external audits and clients under a consent decree or experiencing 483’s observations.
• Engaging in QA/QE and Business Analysis, including CAPA’s, OOT/OOS/IR/DR investigations, change control / risk management and FMEA, data analysis, SAT/FAT, metrics.
• Developing SOP’s, Policies, User, PM, Cal, QA, Admin procedures.
• In the area of Med Devices & IVD's industry, also, providing DHF, DHR, DS, V&V, device dev support, developing u/d/pFMEA's.
• Managing/supervising team of QE’s and Project Managing complex remediation, implementation, product transfer (including scale-up) and development activities.

San Diego, CA, US

1st Phase: TMV's----------------------------------------------------------------------------------------------------------o Authoring, executing, reviewing, and approving: Gage-R&R, TMV’s (Cat 1-4: ID, Quantitative, Limit, Content/Potentcy, Function/Performance: accuracy, precision, repeatability, specificity, detection/quantitation limit, linearity, and.

• Diagnostic Laboratory (21 CFR Part 58 GLPs).
• GLP Lab preparation activities.
• ERES assessment and validation activities
• Validation of Lab Equipment (e.g. Beckman centrifuge, BioTek microplate reader, Gen5, etc).

Class 3 Medical Devices.* Generated Site and Facility/Utility Master Validation Plan.* Assisted in development / implementation activities for mechanical, IT Network infrastructure, electrical, plumbing, ESD / Cleanroom (class 7 & 8), process gases, compressed air, architectural, IT Infrastructure, and Backup Generator, design specifications per facility.

Foster City, CA, US

• With respect to Lab Systems, responsibilities consist of SDLC activities per GAMP5, 21 CFR Part 11 and Annex 11:o Assessed for regulatory and corporate compliance of: Master Validation Plan(s), Requirement.

Fridley, Minnesota, US

• Class 3 Medical Devices.
• Directed a team of quality engineers in product integration project.
• Generated Quality and Process / Equipment / Design Validation procedures / procedures / policies.
• Generated dFMEcA and pFMEcA for stent product of an acquired stent manufacturer, “Reverse Medical”.
• Performed gap analysis of current manufacturing and design/process against DS, clinical data, and DHF documentation. This included generation of remediation plan for quality relevant documentation, dimensional and.
• Improved and created inspection points / test methods.

Abbott Park, Illinois, US

• Generated compliance gap asmt on process & data analysts (by shadowing/investigations), CatsWeb SQL dBase and SAP per FDA, EMEA, HCan, CFDA, CDSCO, MHLW, TGA, MHRA, AMO global, & divisional policies & regulations with.
• Created 21 CFR Part 820 / ISO 13485 (GxP), 21 CFR Part 11 / Annex 11 (ERES) compliance gap remediation plans and risk assessment, which included implementation & integration with existing technology (i.e. SAP Business.
• Revised existing process & validation SOP’s to comply with GxP, ERES, global, divisional policy.
• Generated technical Work Instructions (WI) for Adverse Event (AE), MDR, quarterly & annual product safety / complaints trending & data acquisition process between CatsWeb and SAP.
• Performed gap analysis, generated a remediation report, & Validation Protocols for PMS (post market surveillance), AE, MDR, and Complaints Tracking spreadsheets.
• Generated VMP, Risk Assessment, URS, DS, FS, IOQ (including test cases), Trace Matrix, and Summary Report for complaints trending & process capability study spreadsheets.

Tel-Aviv, IL

• Authored Requirement Specifications (i.e. URS, FS, SDS) and functional Test Scripts for Waters ELN Forms used at Teva North America / Teva Pharmaceuticals.
• Authored requirements and test scripts in Quality Center v10.
• Authored SDLC documentation such as Validation Master Plan (VMP).
• Resolved deviations in Quality Center and TKS.
• Trained technical owner on GxP / 21 CFR Part 11 (ERES) requirements and testing scripts.

Tel-Aviv, IL

• Maintained and assured compliance of current/new Computerized & Automated Systems:o Assured the compliance of requirements with respect to system, user, procedural, interface, data, business, and regulatory.
• Additional responsibilities consist of:o Supported CAPA process as it relates to Deviations, Complaints, Investigations, Observations and OOS.o Reviewed, revised, and approved Admin, Use, Method, Assay, Instrument, and.

Tel-Aviv, IL

• Authored and executed Validation Documents (SDLC documents: VMP, FDS, URS, SCS, IQ, OQ, PQ, TM, VSR, Admin SOP, Change Management documents) for Laboratory Systems / Instruments and Engineering Controls.
• Performed periodic review of software / system, Part 11/ ERES assessments and prepared formal reports.
• Revised and assisted in revision/creation of SOPs with respect to Use, Administration, and Maintenance. Some of the Systems Remediated to-date: Leica Mic, IC Chromeleon Dionex, AA ThermoScientific.

Geneva, Switzerland, CH

• For LensX:
• Provided Chemical assessment and compliance activities per CERCLA Emergency Planning and Community Right to Know Act, Hazardous Materials Transport Act, Toxic Substances Control Act and OSHA health Act.
• Interacted and coordinated compliance activities including completing forms for agencies: OCFA, EPA, OSHA, DOT and corporate insurance agents.
• Prepared appropriate documentation, required forms, informed agencies on status and coordinated inspections.
• Authored and executed facility, utility, and equipment validation protocols and provided guidance on safety and regulatory needs per ISO 13485, QSR, GMP, EPA, OSHA, OCFA, and FDA regulations.

Thousand Oaks, CA, US

• Created Quality Department’s Project Plan and Resource Predictor Model for product life cycle: pre-clinical, Phase 1/ 2/ 3, regulatory filing, commercial and contract manufacturing.
• Defined structure and business needs.
• Provided suggestions on quality resources and budget requirements.
• Organized meetings and review with executives/stakeholders, gaps / inconsistencies within resourcing and budgeting.

Rancho Santa Margarita, CA, US

• Developed all GAMP required SDLC documentation for validation of SAP modules in CA, Europe, and Australia.
• Development of blueprints, landscape design, technical architecture, system requirements specifications, functional design specifications, risk analysis, traceability matrix, unit/integration test scripts and other.
• Trained team on GMP/GDP/ISO/QSR/EMEA regulatory needs and validation process.
• Validated the WM-RF Barcoding, FICO, MM, PP, SD, CO, and FI modules.
• Consulted and audited WLAN, RF site survey and stress testing scripts, execution and reports.
• Developed, maintained, and tracked validation deliverables

Irvine, CA, US

• Many of Edward's components, raw material, and textile assembly/manufacturing vendor sites were ending contracts with Edwards, ceased to produce the materials needed, or were needed for new devices. Provided support in.
• Reviewed / commented / approved: FMEA’s, specifications, drawings, protocols and data which would be later submitted to the agency, corporate, site executives/management.
• Generated reports and remediation action items based on gaps / deviations.
• Performed statistical analysis on data gathered by field CQA's and Quality team members.
• Reviewed for compliance and adherance to FDA regulations / standards and device requirement specifications: o Statistical analyses protocols o Test Methods used and TMV's o Validation plans o Sampling plans o SPC.
• Provided guidance / training based on statistical analysis, FMEA, sampling plan, and compliance against ASTM/ANSI regulations / standards.

• ERES VALIDATION SPECIALIST CONSULTANT (Aug 2006 - Dec 2006)
• Executed QNX embedded software GUI test scripts on the FS Laser system.
• Documented deviation observations, resolved / mitigated, and re-executed.----------------------------------------------------------------------------------------------------------QUALITY ENGINEER / VALIDATION.
• Authored / executed assembly equipment (e.g. IOQ/PQ on cone adhesive system), facility / utility, and process validations.
• Executed equipment, test methods and ERES compliance audit.
• Prepared safety, chemical storage, and industrial hygiene assessments / reports.

Seal Beach, CA, US

• Developed statistical method / plan, performed statistical analysis, DOE, sample size and number of runs determination, and established efficacy acceptance criteria for Provenge immunotherapeutics Process Validation.
• Evaluated statistical data to make determination regarding molecular, cellular, and protein efficacy & potency data for IND and NDA submission to the FDA.
• Developed cleaning validation method for Commercial Immunotherapy Manufacturing Facilities.
• Developed Risk Analysis and pFMEA for systems, documentation and manufacturing processes.
• Supported Biostatistics department with respect to clinical studies in SAS.
• Provided general statistical training to Quality Assurance members.

FR

Assisted in strategies / methods for technology transfer from Switzerland and France to production in Eastern Europe with respect to 91/412/EEC.

Santa Ana, CA, US

• Validated Blue Mountain Calibration System 4.0.
• Created master validation for in-house databases and DataStream MP2.
• Created proposals and coordinated validations activities with IT (Computer) department.
• Negotiated discounts with software vendor.

Deerfield, Illinois, US

• Assessed ERES compliance over many US and International facilities.
• Maintained an inventory of over 2000 manufacturing GxP system including validation compliance, ERES compliance, SDLC remediation responsibilities, calibration, remediation tasks, budget, and SDLC documentation status.
• Provided reports/status updates to management on a need to know basis.
• Researched best ERES solutions / technologies for Part 11 compliance, global implementation, user friendliness, and budget.
• Performed Global ERES budget analysis & applicability.
• Developed & Maintained Development Life Cycle (SDLC) Validation documentation for global manufacturing computerized systems and software.

Reno, NV, US

• Provided professional guidance on 21CFR Part 11 requirements and software validation needs for CatsWeb.
• Audited existing procedures and developed CatsWeb software validation.

• Validated lab and manufacturing equipment, test methods, facility, and manufacturing processes.
• Oversaw V&V and design transfer.
• Provided technical training to technicians and lab personnel (e.g. GxP’s, ISO, QC techniques, sampling, etc)
• Provided assistance in the lab, production and warehouse.
• Created supplier and vendor audit procedures, process, and performed/executed as needed.
• Maintained Material Review Board, Quarantine and Approval process.

Melsungen, DE

• Validated / re-qualified equipment, new or reworked product, systems, PLC's, and facilities.
• Investigated returned product complaints and documented findings.
• Provided technical training and assistance to other junior QE's.
• Assisted in GxP related activities during plant shutdown operations.

Bethlehem, PA, US

• Performed environmental monitoring (e.g. air, surface, WFI / UP / DI / City water & product, personnel, steam, clean compressed air and return steam).
• Assisted in sterility testing of final product.
• Performed CAPA investigations of production incidences and performed trending.
• Performed microbiological ID.

Dublin, Coolock, IE

• Performed environmental monitoring testing.
• Performed chemical (Gas Chromatography, FTIR, and HPLC) and microbiological (endotoxin and bioburden) testing on IOL's (IntraOcular Lense and components).
• Performed 209E trending and completed related forms/reports..

Bachelors Of Science, Biological Sciences, (Microbiology)

21 Cfr Part 11 (Eres), Regulatory

Network Administration & Web Development, Information Technology

Associate Of Science (A.S.), Psychology