Quality Assurance Medical Device

SHARIFF E. MÉNDEZ FERREIRA

**** ******* **** **, *******, TX 76131

E-MAIL: *******@*****.***

PHONE: 787-***-****

Background Summary • Over nineteen (19) years of successful experience in positions of increasing responsibility in the pharmaceutical (solid dosage, liquids, and medical device), biotechnology, consumer products and cosmetic industry. Highly experienced with Industries under the FDA Consent Decree.

• Strong background in Compliance, Commissioning, Qualification, Validations (Computer Systems, Equipment, Facilities, Process and Laboratory), Auditing, and Regulatory Compliance. Knowledge of federal and international GMP regulations (FDA 21 CFR Parts 210, 211, 820, Part 11, ISO, and EU), and guidelines (GAMP 4 & 5, ER/ES, GxP, ISPE, and ICH).

• Extensive experience in the creation and execution of System Development Lifecycle (SDLC). Experience includes: 21 CFR Part 11 assessments and remediation planning, software quality assurance, systems and software supplier audits, management of validation policies/procedures/guidelines for computerized systems, software validation for FDA regulated systems, including systems requirements, specifications, design, testing, configuration, change management and auditing.

• Expertise covers from Development and Field execution of IOPQ protocols and reports, Technical Documentation, QA Audits, and Compliance for Packaging, Manufacturing Process and Utilities. Excellent service provider focused on customer satisfaction for pharmaceutical and medical device industry.

Experience 2006 to Present Independent Professional Services USA & Mexico

Senior Validation Consultant/Validation Compliance

Project company names: Reckitt Benckiser – Texas, Ben Venue Laboratories – Ohio, Alcon Laboratories – Texas, Sophia Laboratory – Mexico, AVON Products – Chicago & Ohio, Wyeth Consumer Healthcare Products, Glaxo-Smith-Kline, Abbott Biotechnology & Diagnostics Ltd. – Puerto Rico.

• Performed qualification and process validation of a sterile vial filling machine, stopper and washer vials of varying configurations. Developed operating Cycle Development and equipment loading configurations for steam sterilizers and depyrogenation equipment. Performed Computer Validation of automated equipment including packaging equipment, inspection systems & aseptic processing equipment to ensure compliance with CFR Part 11.

• Performed cGMP compliance audit and self-inspection to evaluate the overall cGMP compliance of the solid dosage manufacturing facility. Provide technical support to perform Process Validation Protocol for Solid Dosage on the Blending, Granulation, Compression and Packaging areas.

• Performed audits of qualification, validation, gmp and quality systems. Provided summaries of status and remediation plan. Worked with company to implement remediation under FDA’s Consent Decree. Responsible in developing Computer Systems Validation Methodology, following FDA Regulations (21 CFR Part 11 and 21 CFR 820) and GAMP 5, such as Standard Operating Procedures, Site Validation Master Plan, templates and trainings.

• Design and deployment of MES systems to replace paper based or manual systems including batch records, weight & dispense, warehouse management and material tracking in a pharmaceutical environment. Developed SDLC and validate ERP, Wizards, MES system integration with the SAP system and/or control equipment (HMI, PLC, and Network).

• Responsible for the management development and execute validation documentation including Risk Assessment, Remediation Plan, User Requirements, Validation Plan, System Design Specifications, Functional Specifications, Configuration Specification, 21 CFR Part 11 Assessment, Risk Analysis, Traceability Matrix, Commissioning, IQ/OQ/PQ, Process Validation and Summary Reports for Manufacturing (MES, SCADA, Granulation, Compression, Blender, Coater, Encapsulation machine), Packaging (Sterile Vial Filling machine, Stopper Vial, Filler, Capper, Cottoner, Weigher, Blister, Labeler, Vision System, Bar Code System, Cartoner, Sealer, Wrappers, Robot Palletizer), Facilities, Utilities (HVAC, Compressing Air, Chiller, WFI, CIP), Information Technology (SAP R/3, GEDMS Documentum, Spreadsheets) and Laboratory (Sterilizer Steam, Hot Air Oven, Incubators, Freezer, Stability Chamber).

1999 to 2006 Kendle Regulatory Affairs (formerly AAC Consulting Group) Rockville, MD

Senior Validation Consultant - Validation Compliance

Project company names: Schering-Plough Products – Puerto Rico & New Jersey, Boehringer Ingelheim Chemicals – Virginia, Caraco Phamaceutical Laboratory, Inc. – Michigan, Beiersdorf Inc. – Connecticut, IPR Pharmaceutical, Inc. (Astra Zeneca) - Canóvanas, PR.

• Provided Validation (Third Party) consulting services during the generation and execution of protocols and reports. Reviewed and approved Commissioning, Installation, Operational and Performance Qualification Protocols, Reports and related documentation for Computerized Systems, Equipment, Laboratory, Utilities, Facilities and Process Validation fields. Support in trouble-shooting activities by providing expertise, recommendations and corrective actions under a FDA’s Consent Decree.

• Performed Gap Analysis and compliance audits on existing operations/documentation and supporting client’s development of a remediation plan to address their deficiencies. Assisting and conducting laboratory compliance assessments, equipment qualification and validation. Assisting in development of SOPs, calibration programs, preventive maintenance, systems integration and change control. Work with clients to evaluate systems and operations for compliance against both internal policies and FDA regulatory compliance.

• Responsable for auditing and assessing the Computer Systems Validation and 21 CFR Part 11 and 21 CFR 820 programs to meet hardware and/or software regulatory requirements, and specification concepts for new or existing (legacy type) systems.

• Responsible for developing and executing CSV Methodology, Change Control, Validation Plan, Remediation Plan, FAT, Test Scripts, Commissioning, IQ/OQ Protocols and Summary Reports for Manufacturing, Packaging and Laboratory equipment and systems.

• Responsible for developing and executing validation plans, commissioning protocols, systems validation reports, specifications and Electronic Records/Electronic Signature (21 CFR Part 11) Gap analysis for associated computer systems. Execution of validation tests (FAT, SAT, IQ, OQ, and PQ).

• Performed evaluation of changes to validated systems in order to ensure continued compliance posture. Communication to management of validation effort status, resource requirements and issues. Maintenance of validation portfolios to ensure compliance with regulatory requirements for computer based system validation.

1996 to 1999 Raytheon Engineers & Constructors Hato Rey, PR

Computer & Equipment Validation – Validation Project Leader

Project company names: McNeil Consumer Healthcare and Ethicon (Johnson & Johnson) – Puerto Rico, Fersinsa Gist-Brocades - Mexico, Merck Sharp & Dohme, Medtronic & Alcon Laboratories – Puerto Rico.

• Provided technical service support for solid dosage, liquid and blister manufacturing enviromental, including blending, encapsulation, compression, packaging, shipping and information technology applications. Coordinated, prepared and executed commissioning verification, equipment, utilities, facilities qualification and systems/process validation activities.

• Responsible in leading validation projects by preparing validation protocols and reports. Monitored and evaluated changes to validated systems to ensure continued compliance and re-validation as appropriate. Functional responsibility for developing, implementing and coordinating validation strategies for computerized systems and equipments. Supervised and coordinated implementation and compliance consulting services at different validation projects and customer facilities.

• Responsible for developing and executing System Development Life Cycle (SDLC) validation documentation, including Risk Assessment, GAP Analysis, Remediation Plan, Validation Plans, User Requirement Specifications, System Design Specifications, Functional Specifications, Configuration Specifications, Traceability Matrix, IQ, OQ and PQ protocols, and Validation Reports for Packaging (Bottle Scrambler, Filler, Blister, Cottoner, Labeler, Vision System, Cartoner, Bar Code System), Granulation, Blending, Compression, Facilities, Utilities (WFI, CIP, SIP, HVAC, Air Handling Units) and Laboratory (Autoclave, Oven, GC, HPLC, Freezer) areas.Developed and executed validation documentation for the Information Management Systems area, including Computerized Site Validation Master Plan and Programmable Devices Security System.

• Performed project management functions (project focus, timelines and tracking, risk assessments, organizational impact and requirements, cost estimates, requests for funding, formal and informal presentations, organizing/coordinating/executing assignment application) for all validation aspects of GXP applications at different projects and customer facilities.

1991 to 1995 Pfizer (Warner-Lambert, Inc.) Vega Baja, PR

Packaging & Validation Engineer

• Developed and executed validation plans, protocols, report, and deviations for associated packaging equipment and systems. Monitoring and evaluation of changes to validated equipment in order to ensure continued compliance posture. Participation in commissioning, qualification and validation execution tests (IQ, OQ and PQ).

• Developed and implemented programs for qualification and certification of packaging equipment under a FDA’s Consent Decree.

• Provided technical support during FDA inspections and corporate audits.

• Executed trials in coordination with the Research and Development Department for the introduction of new products and/or modification of existing ones.

• Implemented and coordinated industrial engineering projects, such as, motion and time studies, facility layout and production standard studies in order to reduce production costs.

• Revised standard operating procedures. Monitored and developed packaging production standards.

Education 1991 Bachelor Science in Industrial Engineering, Polytechnic University of Puerto Rico.

Skills • Strong knowledge in cGMP’s, FDA regulations and compliance issues, pharmaceutical industry guidelines, trending and practices.

• Strong analytical skills, quick learner, self starter, multi task, analytical and creative. Strong leadership and interpersonal skills. Experience working individually and in groups (team oriented). Training and Seminars Attended: FDA Auditing of Computerized Systems, Quality Assurance and Regulatory Services: 21 CFR Part 11 by EduQuest, Inc., Good Manufacturing Practices (GMP), World Class Manufacturing, PLC and SCADA Validation, Computer Validation and GAMP 4 (ISPE). Maintenance and Troubleshooting PLC 5 using RSLogix 5 Software, and Programmable PLC 5 using RSLogix5 Software.

• Software Skills:

RS PMX Manufacturing Execution System (MES), GEDMS Documentum, Kaye Validator 2000 program, ValProbes Software, Ellab Tracksense, Sensitech TempTale4, Microsoft Word, MS Excel, Power Point, MS Project, Access, Lotus, and Dr. Schleuniger Pharmatron AT4.

• Fluent in Spanish and English.

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