| Candidate Information | | Title | Project Management Business Development | | Target Location | US-IN-Indianapolis |
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Click here or scroll down to respond to this candidateErol Ali Cetinok is the Principle at SynerQ with thirty years of experience in various engineering, compliance, validation, project management and quality roles, as well as business development. Erol has developed a reputation for his consultative approach towards custom designing complete and seamless approaches to address client challenges that incorporate both technical and business considerations.Erol graduated from the Purdue University with a Bachelor of Science degree in Mechanical Engineering, which has given Erol the knowledge base of advanced engineering principles and understanding of technical matters. He also holds a Bachelor of Arts degree from Indiana University in Political Science, which has provided invaluable in comprehending and navigating the regulatory environments. Erol has a minor in Mathematics, and graduate level work in Biomedical Engineering and Business Administration.Erol has a track record of success working with several industry leaders and world class academic institutions in Pharmaceuticals, Medical Devices, Gene Therapies, and Biologics. His services range from auditing against regulatory guidance and quality standards, project management, project planning, protocol development, validation, start-up procedures, testing and implementing quality aspects of systems and facilities for compliance to international standards (ISO) and regulatory compliance (FDA, GxP and EUMDR). Erol is also considered in the industry as an expert in Gene Therapy and its related global regulatory and quality status.Erol served in the US Army as a paratrooper, and currently serves in both the US Air Force (Major) and US Coast Guard (as Division Vice-Commander / previous Flotilla Commander) Auxiliaries.EducationPurdue University Bachelor of Science in Mechanical Engineering, Street Address
Indiana University Bachelor of Arts: Political Science, (Math Minor) 1992Professional ExperienceSynerQ Inc., Indianapolis, IN 2013-presentPrincipal (Quality Systems Regulatory / Validation / Auditor)SynerQ is a consultancy serving the compliance and regulatory needs of the biologic, medical device, and pharmaceutical industries. SynerQs services range from auditing against regulatory guidance and quality standards, project planning / management, protocol development, Validation, start-up assistance and testing of the quality aspects of systems and facilities for compliance to International Standards (including ISO) and regulatory compliance (GxP, Medical Device Regulations-(MDR) and FDA 211 / 820).The following are my clients and a brief description of the services provided:Virbac Animal Sciences St. Louis MO EU GMP ConsultantProvide regulatory requirement advice to R&D for EU GMP. Developed and updated URS/SIA and Validation (IQ/OQ/PQ) protocols. Assisted in Audit and provided guidance to findings. Developed FMEA initiative to mitigate risks to GMP facility.Eli Lilly and Company Indianapolis, IN Project ManagerProvided project management to Lilly for a very high visible implementation on lines for a new product. The NSID (Nude Syringe Identification) project inducing adding four color bands for the self-injecting syringe to identify the dosage for the new BIF Efstora product for diabetes treatment. BIF had a classification level of 5, which is the highest and can cause death if dosed incorrectly. NSID was designed to identify the correct dosage and syringe. It consisted of various equipment on the lines and procedures changes. Commissioning and Qualification assistance was also provided. Was instrumental in ensuring funds was available, submitted a Capital Investment Request (CIR) and Procurement Orders (PO) using Ariba into the Lilly system.Remote, Indianapolis, IN Senior Regulatory Affairs EngineerProvide value added regulatory requirement advice to various companies in the Life Sciences for gene therapy issues, including Ultragenyx, Johnson & Johnson, and a number of start-ups.Zimmer-Biomet Biologics Warsaw, IN Regulatory Affairs SpecialistResponsible for 510K submissions for various Biologics products. Researching and preparing Letter to File (LTF) for various cell and tissue products, including HCT/P. Responsible for some APAC and European MDR submissions. Review Design and Change control documents. Responsible for De Novo Request determination. Review of Labeling, Marketing, Technical (STED) and Surgical instructions for accuracy and compliance to US FDA, EU MDR, MDSAP and APAC.Zimmer-Biomet Spine Denver, CO Regulatory Affairs SpecialistResponsible for European MDR submissions of various brands. Updating files to ensure MDR compliance. Responsible for 510K submissions to the FDA utilizing eStar electronic portal. Reviewed Risk Assessment and mitigation documents for products. Responsible for GUDID and GMDN updates and implementations.Avalign, - Ft. Wayne, IN Senior Regulatory Affairs SpecialistProvided FDA and European MDR regulatory services to Spinal Implant Product. Reviewed FDA 483 audit findings and provided responses to the FDA audit (2017). Assisted in reviewing all product families to ensureEli Lilly and Company Indianapolis, IN Computer Systems Validation Project LeadProvided Computer System Validation (CSV) Project leadership for equipment in the Product Research and Development area for GxP (GLP / GMP) product evaluation for Clinical Trials and pre-production. Solely responsible for development and evaluation of Risk Management process and Master Validation Plan (MVP).Cook Medical Bloomington, IN Regulatory Affairs SpecialistResponsible for submissions to Asia-Pacific (Korea/Japan) regulatory bodies - update legacy products. Updated Legacy Products to meet current regulatory requirements such as design control, risk management, etc. Work with regulatory group to review and update documents to meet APAC (Korea/Japan) standards.Paean Clinical Indianapolis, IN Regulatory ConsultantServices to Start-up with FDA 21 CFR 820 regulations, 510K with CLIA waver submissions. ProvidedHelmer Inc. Noblesville, IN Quality Systems Regulatory EngineerManage FDA audit to 21 CFR 820 regulations:Was company representative person to the FDA auditor during June 2017 FDA auditManage compliance to FDA 21 CFR 820 regulations (cGMP) and ISO 13485Preform gap analysis and prepare the organization to the new ISO 13485:2016 standardSet up registrars audit to new standards for 2018 and interpreted ISO 13485 and Food & Drug Administration (FDA) regulations to guide development of procedures, protocols, and policies for the QMS and production.Responsible for implementing and updating internal audit systemDevelop training process from a non-existent state and regulatory training (GMP, GDP, ISO) to new employees.Kimball Electronics Indianapolis, IN Senior Validation ConsultantPerformed Validation of new and existing processes,Reviewed unresolved legacy Non-Conforming Reports (NCR/CAPA). These were associated with a finding by the FDA during an inspection. Led teams to resolve the issues in the reportsalong with other quality/regulatory needs of the client.Eli Lilly and Company Branchburg NJ Commissioning and Qualification LeadProvided leadership to Lillys ImClone facility in New Jersey for commissioning and qualification to prepare for the Sola project and for site expansion. Developed and wrote C&Q plan. Provided support in other areas, i.e. development of Receiving Verification (RV) system. Project ended, due to Sola failing phase 3 clinical trials.ASICT (Japan)/Navigant Indianapolis, IN Senior Scientific Regulatory AdvisorProvide consulting and support services aimed at satisfying ISO13485 and Japanese MO169 regulations of a medical device company in Japan. Preformed GAP analysis of QMS against US and Japanese regulations. Provided input to QMS of SOPs and rewrote Quality Manual to reflect ISO/MO and current operations.Cardinal Health Indianapolis, IN Senior Validation ConsultantProvide consulting and support services aimed at satisfying FDA compliance for Validation of a Radiological Pharmaceutical contract manufacture to Bayer. Reviewed Validation protocols and reports for (IQ/OQ/PQ) for process equipment. Assisted with other Quality Assurance activities regarding packing and labeling line. Was assigned as the Project lead for the novel product being developed at this facility for all regulatory and validation purposes.PMC SMART Solutions Shelbyville, IN Senior Validation ConsultantProvide consulting and support services aimed at satisfying FDA compliance for Validation of a Medical Device contract manufacture.Developed and wrote new and legacy Validation protocols and reports (IQ/OQ/PQ) for process equipment.Wrote and evaluated Protocols for Software Validation of process and manufacturing equipment.Developed the process for re-validation of process as it was moved from automotive to medical devices.Reviewed and developed Risk Assessment and Management documents and process,Assisted in the evaluation of necessary for new products/clients.Zimmer, Inc., Warsaw IN Senior Engineering Consultant/QualityProvided consulting and support services aimed at satisfying remediation efforts for FDA compliance for the CAPA initiative. Was responsible for reviewing Quality Investigation Reports and various CAPA document in preparing responses to audits findings. Was also responsible for developing and writing reports to finalize various types of CAPA documentation. Assisted client in finding and reporting resolutions to audit finding.Atrium Medical Corporation Hudson, NH Senior Engineering ConsultantProvided consulting and system analysis alone with validation services to satisfy remediation efforts for FDA compliance. Devolved / wrote protocols for compliance to ISO 13485 / 21 CFR 820.Developed Biocompatibility Risk Assessment for Biological Stability for Thoracic products and Biosurgery products. Developed and wrote Test Validation Protocols and Design Verification Reports for Thoracic and Biosurgery products to validate and test for biocompatibility testings.Researched and updated references used in various documents, to ensure that they are relevant to the subject and are in compliance.Researched, defined developed and wrote justification for ISO class 7 clean room particulate standards, and provided evidence to ensure cohesion across all products and components. Justification was used in Quality Plan to support risk mediation for clean room production of various medical devices.Led Design FMEA (DFMEFCA) initiative to review and update existing DFMEAs of current products. Managed Design FMEA (DFMEFCA) team (of three engineers and one representative from Marketing).Hill-Rom, Batesville IN Senior Consultant Lead AuditorLead Auditor support for auditing operations at Hill-Rom Batesville operations for compliance to ISO 13485 and 21 CFR 820.Set up internal audit system, which included an update process and implementation of best practices to ISO13485 standards and 21CFR820 FDA regulationsCreated and maintained audit schedule for internal (1st) and 2nd/3rd party auditsPerformed audits of Quality Management Systems (QMS) including planning /reporting of findingsPrepared audit response to FDA audit of outstanding findings and real time support of auditsTrained and qualified internal auditors to ISO 13485 and 21CFR820Supported CAPA initiative by supporting various CAPA elements in preparing audit response to FDA, including CAPA support of outstanding audits preformed prior to arrival on projectEnergy Delivery Systems (EDS), Indiana Senior ConsultantProject management, consultant, and quality management systems (QMS) support for a start-up company in the biomedical industry. Developed and wrote Standard Operating Procedures (SOPs) for GMP facility in Indiana. Developed Risk Assessment of novel Pharmaceutical. Designed Cleanroom for the production of the product.Eli Lilly and Company Indianapolis, IN Consultant - Commissioning/Validation EngineerProvided consulting to Lilly Diabetic Care Unit (where most of the worlds insulin is manufactured.) Provided system analysis and validation services to satisfy FDA and cGMPs. Prepared, reviewed and executed validation protocols including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for client.Indiana University - Cancer Center, Indianapolis, IN 2006-2013Quality Compliance Specialist Medical Molecular Genetics Vector Production Facility (VPF)Manage compliance to FDA 21 CFR 210 / 211 regulations (cGMP) for IU VPF and NIH-NGVB.Interpreted current Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other Food & Drug Administration (FDA) regulations to guide development of procedures, protocols and policies for production, certification assay testing and molecular diagnostics testing of viral vectors, cell culture and supernatant of Retroviruses and Lentiviruses.oDeveloped and implemented Polices, Standard Operating Procedures (SOP) and other documents; and lead process update efforts to satisfy FDA and GxP requirements for operations, quality and testing of Retroviral and Lentiviral viral vectors.oReviewed and approved all agreements with sponsors and client, all production records (including batch production records (BPR)), all final reports (including certification assay testing) and Certificate of Analysis (COA) before submission to sponsor and clients. Insured compliance and accuracy of all reports before signing and approving.oResponsible for maintaining and submitting to the Drug Master File with the FDA.oWas intimately involved with the implementation of novel production / certification methodsServed as an independent evaluator and advisor who were in a position within the facility to facilitate changes in processes, systems and regulatory compliance implementations.Audited and analyzed processes at IU-VPF; and advised personnel and management regarding regulatory compliance with FDA. Developed and implemented new updated audit system.oAudited IU-VPF (which includes FED STD 209E class 100,000 and ISO 14644-1 class 8 clean room and four (4) FED STD 209E class 10,000 and ISO 14644-1 class 7 clean room suites) for compliance to cGMP and other FDA regulations.oImplemented new compliant value-added auditing methods that followed ISO19011 and QSIToReported results of audits of processes and systems to IU VPF personal for compliance.oTrained personnel and management in cGMP and FDA regulations.oActed as organizational representative for FDA regulatory audits and (2nd/3rd) audits.Led quality and compliance elements of validation of new (2009) aseptic IU VPF Facility.Developed, wrote and/or signed for final approval for all validation documents including the Validation Master Plan, validation SOP, Protocols (IQ, OQ, PQ) and user requirements (USR).Lead Risk Management efforts to assure that process/product were in control.Implementation and development of for all new and legacy process as part of risk assessment management and mediation in an aseptic environment for vector production.oUtilizing Root Cause Analysis (including FMEA) to mediate risks to the client base and patents and resolve process/product failures.oResponsible for creation, documentation (including how-to-document) and implementation of the Corrective Actions / Preventive Actions - CAPA system and process.oInstrumental in developing resolutions to eliminate the causes of non-conformities, findings and issues by leading CAPA teams.oResponsible for monitoring and measuring the effectiveness of both the CAPA system and the resolutions of the CAPA, non-conformities, undesirable situations, findings and issues.Was instrumental in working with the FDA to meet the regulatory challenges and in developing international standards and regulations in this developing area of life sciences.Was responsible for all quality and compliance of the Certification Laboratory and Molecular Diagnostic Testing Laboratory.Certification Laboratory was responsible for a series of assay to test the status of the Cells and Supernatant of viral vectors. Utilizing analytical methods, for a Microbiology Laboratory.Responsible for Good Laboratory Practice (GLP) compliance (including SOP development) and internal audits of the National Institute of Health - National Gene Vector Bio-Repository (NGVB)Engineered Machine Products, Indianapolis, IN 2004-2006Quality Management System Coordinator / Internal Audit ManagerImplemented audit system, ISO9001 and TS16949 in Indiana automotive/truck engine components facilities.Achieved Certifications in Automotive, Off-Road, and Heavy Truck Industries.oImplemented ISO9001:2000 Quality Management System in Indianapolis, achieving certification.oPerformed GAP analysis from ISO9001 to TS16949.oConverted QS9000 QMS to TS16949 in Greenfield facility and obtained certification.oDeveloped and implemented Internal Polices, Procedures and documents for both facilities.oImplemented and trained to the ISO/TS16949 standard at both locations.Lead Auditor and Internal Audit Manager.oCreated QMS Audit system for internal audits and preparation of 2nd / 3rd party audits.oTrained and managed auditors to perform internal audits of all elements of the QMS.Was responsible for risk management and mediation efforts. Utilized Failure Mode and Effects Analysis (DFMEA/PFMEA) for new and legacy products.Led development of CAPA system to meet ISO and automotive standards (ISO9000 / TS16949), and of a system to monitor and measure the effectiveness of the CAPA process and actions.Led major initiatives of the CAPA system to resolve internal quality issues and non-conformities as related to external and internal audits, customer feedback and other avenues.Seat Tech Incorporated, Indianapolis, IN 2000-2004Vice President / Executive PartnerManufactured Automotive seat actuators distributed worldwide. Responsible for Purchasing, Engineering, Production, Materials, Planning, Marketing, and Quality staffs to support domestic and global customers.Achieved record growth and gross profits for start-up in the automotive/after market.Built 100% company growth from Start-up to $10M in four years.Delivered a quality product on time, at a reasonable cost.oBuilt and drove growth Start-up Company from inception.oManaged through new product launch and shipment attainment.oDeveloped a new automotive safety seat recliner system for all-belts-to-seats (ABTS).oLaunched five new programs in 20 months.oInterfaced with domestic, global, and potential customers.oPerformed 2nd Party Supplier quality audits and to various standards (QS9000, ISO family).Developed and implemented engineering, production, and quality processes, including Audits (internal/external), supplier development, Corrective Actions / Preventive Actions (CAPA), SPC, Root Cause Analysis methods, design, production and development controls, Risk Management (and mediation) systems. Utilized and developed Failure Mode and Effects Analysis (FMEA - DFMEA and PFMEA) for new product and new process.Developed Business Plan and presented to clients and potential clients.P. L. Porter Co. Automotive Systems Group, Westfield, IN 1997-2000Product Engineer / Program Manager - European ProgramsDeveloped passenger vehicle comfort control systems for global customersDesigned safety seat system by incorporating new technology for integrated all-belts-to-seats (ABTS) seat recliner for upcoming European vehicles.oResponsible for Failure Mode and Effects Analysis (FMEA) including DFMEA and PFMEA.oLed design review meetings for both internal and customer audiences.oSupervised tests to meet customer and European regulatory demands, such as ECE-14.oTraveled to customer sites and production facilities in the United States and Europe to provided 'on-site' consulting on programs and future products.oAppointed (Customer) Program Manager for new $10M program.Led major initiatives of the CAPA system to eliminate causes of non-conformities and internal quality issues as related to external and internal audits and customer feedback.Responsible for resolution of CAPA findings of non-conformities for program of significant customer base (Domestic and European) and present any outcomes to customer.Managed Pilot Project for SPC / HMI / monitoring of Ford seat recliner production.oUtilizing SPC techniques defined parameters for critical(s) for production.oDeveloped production real-time monitoring utilizing Human Machine Interface (HMI).Presented Process Control plan to management and current/prospective/internal customers.Performance Solutions, Inc., Indianapolis, IN 1995-1996Staff EngineerProvided system analysis and validation to satisfy FDA compliance and GMP of pharmaceutical manufacturer.Project Management in numerous validation projects for clients in pharmaceutical developments.Led portions of client's $158M Biotechnology Development Laboratories validation project.Supervised and trained (5-10) engineers and technicians in developing protocols both in Validation and cGMP protocol development and execution for utility and process systems.Managed project estimating, budgeting, scheduling, and overall project coordination.Delivered the final Validation and cGMP documentation packages for client.Responsible for development of validation master plans of client systems and processes.Developed and wrote Test Design Specification; Standard Operating Procedures, Validation Protocols (installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for process, equipment, facility, and utility systems and processes.Executed Validation protocol functions of systems, equipment, drawing, and software.Performed start-up activities on utility and process systems.Internship ExperienceArburg Maschinenfabrik, Lossburg, Germany 1990Engineering / Business Intern (Fulbright Program)International Academic Business / Engineering Internship studiesMarketing Department: Interacted with global clients on technical and commercial issues.Engineering and Design: Assisted with design and modification of Injection Molding systems.Additional TrainingISO9000 and ISO / TS16949 Lead Auditor Course - Automotive Industry Action Group (AIAG)Good Manufacturing Principles (GMP) Eli Lilly & CompanyPrinciples of Lean Manufacturing BMT CompanyKaizen GD&T FEA Six Sigma Kan-Ban GAMPHuman Machine Interface Software training Rockwell AutomationAdvanced Human Machine Interface Software training Rockwell AutomationProfessional CertificationsCertified Biomedical Auditor American Society for Quality (ASQ CBA)ISO9001:2000 / ISO / TS16949:2002 Lead AuditorAffiliationsASQ American Society for QualityASQ Biomedical Division Midwest Discussion Group - Chair (2008-2009) Vice Chair 2012-2013ASGCT American Society of Gene and Cell TherapyAABM - Association of Academic Biologics ManufacturesASME American Society of Mechanical EngineersSAE Society of Automotive EngineersLanguagesGerman Turkish EnglishMilitaryU. S. Army - Airborne Division paratrooper (infantry and quartermaster)United States Air Force Auxiliary/Civil Air Patrol (2000-Present) (RankMajor)Squadron Commander - (2008-2012)Personnel Officer (2006-2008)Public Affairs Officer (2000-current) Master (highest) LevelUnited States Coast Guard Auxiliary (2016-Present) (RankDVC/Lieutenant Commander)Division Staff Officer (Secretary/Diversity)- (2017-2019)Flotilla Vice Commander (2019-2021)Flotilla Commander (2021-2024)Division Vice-Commander (Present) |
