OSCAR5ACOSTA RAMOS, MS, CFSP, CHA, CPGP, SPCA Personal Cell: 787-315-2651 Business Cell: 787-561-50935
Personal Email: oacosta60@gmail.com Gurabo, Puerto Rico, USA 00778
EDUCATION
Summary of Qualifications
Master of Sciences Degree in Chemistry University of Puerto Rico Rio Piedras, P.R.
Highly qualified and goal-oriented chemist with twenty-seven (27) years of pharmaceutical (Quality Assurance, Quality Control, Technical Service, Manufacturing and Regulatory Compliance) and scientific/technical exposure. Fourteen years (14) of experience working in Pharmaceuticals under Consent Decree (Schering-Plough and Warner-Lambert) developing, establishing and maintaining quality programs. Knowledge of USP/NF, BP, EP, JP, MHRA, TGA, Japan Regulations, FDA Regulations, Food Microbiology, SQF Code, GFSI, Hazard Analysis Critical Control Point (HACCP), Food Code 2013, The New FDA Food Safety Modernization Act (FSMA), Medical Device , CGXPs (GMP, GLP and GCP), ICH, Quality Engineering and Quality Audit Principles, WHO (WORLD HEALTH ORGANIZATION), Food and Agriculture Organization of the United Nations (FAO), PIC/S (Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme)), Computer Literate (Word, Power Point, and Excel), TRACKWISE System, Biological Industries (Part 600,601 and 610), Canadian Regulation, Six Sigma Principles and Lean Manufacturing Principles. College teaching experience. Certified as Food Safety Manager (CFSM), ASQ Certified Pharmaceutical GMP Professional (CPGP) and ASQ Certified HACCP Auditor (CHA). NEHA and Prometric Trainer and Proctor. National Registry of Food Safety Professionals Trainer and Test Administrator. Licensed Structural Pest Control Applicator. Miembro de la Cámara de Comercio del Sur de Puerto Rico
Bachelor Degree Degree in Chemistry University of Puerto Rico Cayey, P.R. SKILLS • Ability to work in a teamwork environment, strong leadership and administrative skills. • Good facilitation skill, problem solving, presentation and negotiating skill. • Ability to instills confidence in others by communication, respect, a sincere belief that they will succeed, readiness to help them do so, and assurance that they will not be penalized when innovative ideas fail. • Ability to provide direction, facilitation, support, reinforcement and coaching to work team. • Ability to gain agreement with team and individuals about short and long term outputs. • Ability to listen, question and understand others beliefs and values. ACCOMPLISHMENTS • Thesis “THE SYNTHESIS AND X-RAY STRUCTURAL CHARACTERIZATION OF COBALT DIOXYGEN COMPLEXES, WHICH MODEL THE ACTIVE SITE IN OXYMYOGLOBIN AND OXYHEMOGLOBIN”. • Schering-Plough Products, LLC Plant Certification. • Warner Lambert Plant Certification. • Chemist License (3177). • Certified Food Safety Manager (National Registry of Food Safety Professional) • Quality Engineer and Quality Auditor Academia.
Professional Experience November, 2010 to Present: ZJX Food Safety Consulting Gurabo, Puerto Rico Owner/President • • • • •
Provide a GAP Analysis and pre-assessment to determine Food Industry needs. Train staff in new policies and procedures, increasing their overall awareness. Improve upon existing food safety practices and procedures. Food Safety, cGMP and HACCP Audit and training. Writer collaborator of Spain Magazine Cielo, Mar & Tierra, Puerto Rico, Gastronomía Puerto Rico Magazine, Náutica Puerto Rico and China Food Safety Magazine.
January, 2008 to Present: Baxter Healthcare of Puerto Rico, Guayama Quality System Team Leader (Superintendant) • Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring conformance to establish standards and agency guidelines. • Provide leadership to a staff of five professional which major quality system responsibility include Track wise, CAPA, Commitments, Change Control, Training (IsoTrain), Investigations, Metrics, Internal SOP, File Room, Corporate SOP, Specification, Manufacturing Master Batch Record and Packaging Modules among others.
1 of 5
OSCAR5ACOSTA RAMOS, MS, CFSP, CHA, CPGP, SPCA Personal Cell: 787-315-2651 Business Cell: 787-561-50935
Personal Email: oacosta60@gmail.com Gurabo, Puerto Rico, USA 00778
EXPERIENCE IMPROVING QUALITY EFFICIENCY AND EFFECTIVENESS During the last almost 23 years, I had had the opportunity to participate in different internal projects to improve the efficiency and effectiveness of the quality control laboratory and the quality system. Project like RightFirst-Time/ Operational Excellence. This project include the following: • Evaluate new technology (Automation) - LIMS, LabWare, TRACKWISE, IsoTRain and more. • Supply Certification and Reduce Testing Program • Training Programs-Cross training to increase flexibility • Analyst Certification • Laboratory Supply • Write and evaluate Operation procedure (SOP), work instruction, analytical method, data sheet, batch record among others. The key goals with this projects included assure compliance with current regulation, analyst efficiency, on time delivery, reduction of overall cycle times for production, release of final product and improve productivity measures for operational cost reductions. TEACHING EXPERIENCES University Professor • Inorganic Chemistry Theory. • Physical Chemistry Theory. • General Laboratory Techniques and General Chemistry Theory. • Organic and General Laboratory Techniques and Chemistry Theory.
Quality System Team Leader (Superintendant) Cont. • • • •
Monitor the implementation of the quality system requirements. Support/facilitate quality system implementation in the site facility. Support CAPA Board Leaders (Quality Vice President and Senior Directors). Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs. • Corporate Quality System Council Member-As a regional member, I represents the interests of the Guayama business. Reviewing all new / revised CQPs. Acting as Change Control Board for Corporate Quality Policies (CQP). Circulate new/revised CQPs to impacted people within business. October,2007–December, 2007: B. Braun Medical Inc (Central Admixture Pharmacy Services), TOTOWA, NJ and Wallingford, CT Quality Assurance Consultant ( Sterile Solutions)-Contract Job • Ensure the integrity and sterility of admixtures sterile preparations (Intravenous solutions, IV). Terminal sterilization, filtration and/or aseptic process. • Audit/assess production records for correctness according to cGMPs and established procedures as required. Note and report deviations. Assure that corrective action has been taken on observations. • Review Installation Qualification, Operational Qualification and Process Qualification Protocols and Report for compliance and make recommendations. • Identify areas for improvements, processes and impact assessment to quality according with procedures, specifications and related regulations to assure compliance. February, 2007 – June, 2007: Wyeth, Guayama, PR –Compliance System Solution Lead Investigator (Quality Assurance)-Contract Job • Revise and investigate laboratory discrepancies related to the Manufacturing, laboratory, Incoming, Quality Technology Transfer, Packaging PPU or any other related area.
June, 2002 to December, 2006: Schering-Plough Products LLC, Manatí, P.R. (Consent Decree Operation) Chemical laboratories Manager (Team Lead); Raw Material, Incoming and Water System • Provide leadership for compliance with quality standard and regulation. • Manages and supervises the Chemical laboratories activities in an efficient manner assuring compliance with procedure, corporate policies and government regulations. • Assures that the testing of Raw Materials, Sampling Materials as well as Water Testing is performed in accordance with internal procedures and/or compendia requirements. • Backup the Director position in the event of absence and relevant meeting. • Direct and implementation of Quality Control and Quality Assurance program and compliance with all requirement.
2 of 5
OSCAR5ACOSTA RAMOS, MS, CFSP, CHA, CPGP, SPCA Personal Cell: 787-315-2651 Business Cell: 787-561-50935
AUDIT EXPERIENCE • • • • • • • • • • •
Suppliers. Manufacturing Area. Packaging Area. Quality Area. Labeling. Incoming. APR. NDA. Complaints. API Area. Contractors.
COMPETENCIES BACKGROUND
• Regulatory Agencies. • Team Leadership and Mentoring. • Laboratory Functions. • Planning. • Safety and Compliance. • Consent Decree Operation (14years). • Communication. • Auditing. • HACCP Auditor Certification LANGUAGES • Spanish and English PROJECT MANAGEMENT SEMINAR • Project Execution Management. • Effective Project Management. VALIDATION / QUALIFICATION • Analytical Method Validation. • Decommissioning (Plant Phase Out). • Equipment Qualification.
Personal Email: oacosta60@gmail.com Gurabo, Puerto Rico, USA 00778
Pharmaceutical Experience (Continue): In-Process Manager • Manages and supervises a group of Sr. Analysts, Technicians, Analysts and Supervisors working in an API (Active Product Ingredients) three shifts Bulk Manufacturing Chemical Plant. • Provide leadership for compliance with quality standard and regulation and to facilitate the continuous improvement of process and product quality. • Develop effective goal setting, both short and long term to ensure that quality performance is maintained at optimum level. • Provide to the Quality Control/ Quality Assurance staff, Operation Managers, Supervisor and colleagues, guidance and services in resolving quality problems. • Backup the Director position in the event of absence and relevant meeting. Stability Interim Manager • Manages and Coordinate the laboratory activities to assure compliance with Stability Protocols and Regulatory requirements. • Ensure compliance with cGMP’s, GLP’s and Safety Regulations. • Serves as liaison between the Stability Administration Area and Worldwide Regulatory Affairs. • Organize daily schedules to ensure that stability time points are completed according to standard procedure in a timely manner. • Improve systems to promote, facilitate and ensure compliance with external and internal regulations. • Backup the Director position in the event of absence and relevant meeting. February, 1995 to June, 2002: Warner Lambert Inc., Fajardo, P.R. (Consent Decree Operation) Quality Control/ Quality Design Manager • Provide leadership for compliance with quality standard and regulation and to facilitate the continuous improvement of process and product quality. • Develop effective goal setting, both short and long term to ensure that quality performance is maintained at optimum level. • Interact with professional, trade, and regulatory bodies outside the firm; interact with scientific, financial and regulatory department inside the firm. • Provide to the Quality Control staff, Operation Manager, Supervisor and colleagues, guidance and services in resolving quality problems. • Review, evaluate, and approve Process Validation Protocol, Technology Transfer, and Product Summaries to new or transfer products. • Prepare Capital Expenditure. • Recruit, train, develop, and motivate quality personnel. • Interpret and assure that all GMP and applicable regulation are followed. • Create new or improve existing SOP to promote, facilitate and ensure compliance with external and internal regulations. • Assists internal group on the transfer of new and existing products. • Ensures timely updates of methods and test results to support all NDAs and DMFs.
3 of 5
OSCAR5ACOSTA RAMOS, MS, CFSP, CHA, CPGP, SPCA Personal Cell: 787-315-2651 Business Cell: 787-561-50935
PROFESSIONAL DEVELOPMENT/ TRAININGS • Safety & Security (OSHA Regulations). • Trainee of Trainers Certification. • Total Quality Management (TQM). • Effective Leadership and Motivation Workshop. • Change Control Management. • Root Cause Analysis. • Technical Writing Skills. • Kepner-Tregoe (Problem Solving and Decision Making). • Quality Risk Management • Conflict Resolution • Technology Transfer • Management and Organization Behaviour. Complaint Experience: • Administrate the Warner Lambert site product complaint system. This include generate, reviewing, approving and directing/leading complaint investigation, generate reports and present metrics. • Interacts directly with internal manufacturing and packaging unit. • Insure timely investigation and closure of customer complaints. • Serves as liaison between the Complaint Site Administration Area and Worldwide Complaint Affairs. • Experience leading cross-functional teams, and the ability to handle multiple projects simultaneously. • Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
Personal Email: oacosta60@gmail.com Gurabo, Puerto Rico, USA 00778
Pharmaceutical Experience (Continue): Quality Design Scientist Supervisor • Lead Quality Investigation group to support the Manufacturing Investigation System. • Ensure timely completion of investigation, identification and implementation of corrective and preventive maintenance. • Supervise the QC instrumentation area (Calibration and Preventive Maintenance). • LRB (Laboratory Review Board) Chairman – This position consists of reviewing, approving and directing/leading laboratory investigation reports and other information related to out-of-specification results, questionable results and laboratory investigation. Generate metric report. Establish effective CAPA. Evaluate European, British and Japanese Pharmacopoeia and Food Chemical Codex changes for the Puerto Rico sites (Fajardo and Vega Baja) once a month and assuring that both sites are in compliance. • Supervise the scientists and quality control technical area. • Evaluate new methods and new technologies. • Approving and directing/leading new Technology Transfer. • Backup the Director position in the event of absence and relevant meeting. Quality Engineer (Quality Assurance) • Review the information contained in the NDA to update Product Annual Report for completeness and accuracy. • Administrate the site product complaint system. This include generate, reviewing, approving and directing/leading complaint investigation, generate reports and present metrics. Interacts directly with internal manufacturing unit. • Insure timely investigation and closure of customer complaints. • Serves as liaison between the Complaint Site Administration Area and Worldwide Complaint Affairs. • Review discrepancy and deviation reports generated during manufacturing and analytical activities and make recommendations for corrective action.
4 of 5
OSCAR5ACOSTA RAMOS, MS, CFSP, CHA, CPGP, SPCA Personal Cell: 787-315-2651 Business Cell: 787-561-50935
RESEARCH EXPERIENCE • Associate Investigator. • Research Assistant. SPECIAL KNOWLEDGE • • • • • • • • • • • • • •
CGXPs (GMP, GLP and GCP) ISO (9001, 13485) Guidelines. ICH. European Regulations (Rules and Guidance for Pharmaceutical Manufacturer and Distributors). General microbiological knowledge. HPLC, GC, FT-IR, AA, Dissolution Apparatus, and other instrument troubleshooting. Knowledge of statistical process control. Computer Literate: Word, Power Point, and Excel. TRACKWISE System. Problem Solving (Kepner-Tregoe). Biological Industries (Part 600,601 and 610). Clinical Regulation. Medical Devices/QSR Food Code Regulation
REFERENCES • Efraín Montero, Presidente de la Cámara de Comercio del Sur de Puerto Rico. • Liz Corchado Torres, Director of Compliance, National Registry of Food Safety Professionals.
Personal Email: oacosta60@gmail.com Gurabo, Puerto Rico, USA 00778
Pharmaceutical Experience (Continue): Regulatory Compliance Coordinator • Establish an internal audit program to effectively assess the different pharmaceutical areas. • Organize resources appropriate to execute the audit program. • Audit the Quality Control Laboratory, Quality Control Technology, Microbiology and Stability Areas. • Audit all the investigation generated at the Quality Control Department. • Assess the manufacturing batch records and related document compliance to established requirements. • Audit/assess production and quality control records for correctness according to NDA, cGMPs and established procedures as required. Note and report deviations. Assure that corrective action has been taken on observations. • Review Installation Qualification, Operational Qualification and Process Qualification Protocols and Report for compliance to regulatory requirements. • Assist Quality Assurance and Regulatory Compliance Director during federal or local government inspections of the plant for compliance. • Conduct audit to the stability data and submit all required information for the preparation of the Annual Report. • Ensures that quality agreements are in place with the suppliers, contractors and affiliates and audits for compliance • Ensures that appropriate specifications and procedures pertaining to products are on file. • Coordinate and manage site inspections by external regulatory agencies and customers. February, 1988 to February 1995: Ortho McNeil Pharmaceutical Inc., Manatí, P.R. Finished Product, Stability and Raw Material Group Leader • Approve or reject components, labeling, finished products (Tablets, Gels and Creams) and Raw Materials. • Develop, review and implement SOP's for new procedure and equipment. • Interact with professional and regulatory bodies outside the firm. • Handle failure investigation. • Co-ordinate, supervise and plan the everyday work in the raw material, stability and finished Product area. • Participate in the material/planning meeting. • Arrange or co-ordinate outside laboratory testing. • Prepare purchase requisitions for new equipment. • Participate in method transfer and product/ equipment validation.
5 of 5