Compliance/Vlidation Professional

VALIDATION / COMPLIANCE PROFESSIONAL

SUMMARY OF QUALIFICATIONS

High performing pharmaceutical industry professional with more than 20 years of comprehensive experience in process optimization, and instituting new critical operation units (change control, pharmaceutical technical services). Extensive experience in regulatory compliance, qualification and validation of: processes, facility, equipment, and computer systems. Well-respected technical/compliance leader with a proven record of strategically developing, establishing and managing technology and compliance infrastructure to grow generic and brand products: Watson, Pfizer, Syntex, and CorePharma LLC.

CORE COMPETENCIES

Process/Computer Systems Validation Computer Systems Lifecycle

Change Control Process Optimization

21 CFR Part 11 Project Management

Tech Transfer Quality Systems

PROFESSIONAL EXPERIENCE

INDEPENDENT PHARMACEUTICAL VALIDATION/COMPLIANCE CONSULTANT 6/2011-8/2012

QUANTIC GROUP/CONTRACT: Compliance and Sustainability Initiative Project SUFFERN NY

Team member responsible for reviewing all validation documentation (Process, Packaging, Computer Systems, Test Methods, Equipment and Facility) to determine compliance with current regulatory requirements and established policies and procedures. Advice on the course of action for remediation efforts on an interim basis while Quality Systems are revised as per compliance review findings. Assist in the determination and implementation of corrective actions.

PHARMACEUTICAL TECHNOLOGY MANAGER 12/2009-6/2011

COREPHARMA LLC MIDDLESEX, NJ

Responsible for managing the execution of validation studies and process optimizations. Interact with Laboratory, Research, Manufacturing and Planning departments in the coordination and execution of cleaning validation studies. Assess proposed changes to validated processes to determine impact and course of action. Create review and approve standard operating procedures pertaining to manufacturing and packaging processes activities such as sampling operation, cleaning, and testing. Perform due diligence pertaining to manufacturing process and validation supportive documentation on potential new acquisitions. Provide technical support to the manufacturing and packaging departments. Assess manufacturing equipment performance and provide recommendations to the Engineering department. Review and approve equipment, facility and critical utility qualification protocols and reports. Negotiate contracts reporting to PT with the objective of addressing compliance gaps identified via internal and external audits. Manage crew of four along with additional contractors handling companywide initiatives.

Notable Contributions:

Successfully instituted new Pharmaceutical Technology group.

Set the foundation of the Pharmaceutical Technology department’s functions via creation and implementation of the Company’s Validation Policy, Site Validation Master Plan, Process Validation Master Plan, Cleaning Validation Policy and Cleaning Validation Master Plan.

Assessed entire coated product line with the objective of determining areas for improvement and to address quality /compliance initiatives. Recommendations included process steps, formulation and equipment

Implemented enhanced new batch records format that provided clearer instructions that promoted better documentation of the process. Implementation included extensive training sessions.

Implemented new process validation protocol format and content addressing current cGMPs and process validation requirements.

INDEPENDENT VALIDATION CONTRACTOR 2008-12/2009 CARMEL, NY

Project 1: Executed commissioning of new biological facility.

Project 2: Executed and completed IQ/OQ testing on computerized system to be used in the compilation and management of data pertaining to biological products.

Project 3: Assessed process validation data and prepared reports. Served as a resource on the new Change Control System to be implemented on a solid dosage operation.

SENIOR VALIDATION SPECIALIST 2004-2008

PFIZER BROOKLYN, NY

Reviewed and approved all validation documentation (i.e.: Validation Project Plans, User Requirements and Specifications, Traceability Matrixes, IQ/OQ/PQ, Qualified Procedures, Retirement Plans) and change controls pertaining to packaging and computer systems. Prepared and maintained Packaging Process, Laboratory Equipment and Computer Systems Master Validation Plans. Worked in conjunction with IT in determining 21 CFR part 11 requirements and in designing required testing. Prepared reviewed and approved Master Production Records. Serve as compliance matter expert on the fields of Computer and Packaging Validation. Reviewed and approved Annual Product Reviews. Chaired Packaging and Computer Systems Validation Committees. Prepared. Reviewed, and approved Standard Operating Procedures (SOPs) relevant to the validation programs. Prepared Cleaning Validation reports. Reviewed and approved proposed changes to container closure system components for different markets/under different regulatory agencies (i.e.: FDA, MHRA, ANVISA). Supported internal and external audits.

Notable Contributions:

In collaboration with the Packaging Dept designed generic Packaging Process Validation with the objective of streamlining the validation process.

Designed and created dept database (ACCESS) used to track change controls, validation documentation, and corrective actions.

Designed /created reports (extracting data from the department’s database) that were used for the generation of the validation section assessment to be included as part of the Annual Product Review Report.

MANAGER OF THE CHANGE CONTROL AND VALIDATION DEPARTMENT 1996-2004

WATSON PHARMACEUTICAL CARMEL, NY

Managed Change Control Program for facilities, equipment, processes, and computer systems. Managed Incident Reporting for Computer Systems. Reviewed ANDA/NDA product development, and validation documentation.

Reviewed and approve master packaging records. Provided site training related to computer systems regulatory/compliance requirements. Steered the site Compliance Gap/Risk Assessment Project for computerized systems. Collaborated in the design of the Computer Validation and 21 CFR Part 11 procedures and policies at the corporate and site level. Managed group comprised of three specialists and one coordinator.

MANUFACTURING SPECIALIST 1995-1996

WATSON PHARMACEUTICAL CARMEL, NY

Managed the update of all existing SOPs related to manufacturing. Created and implemented SOPs to address compliance issues previously identified through external and internal audits. Conducted and documented investigations. Prepared and executed packaging equipment qualifications.

TECHNICAL SERVICES SPECIALIST 1994-1995

WATSON PHARMACEUTICAL CARMEL, NY

Coordinated and executed process validation studies (protocol preparation/execution, report preparation).

TECHNICAL SERVICES SPECIALIST 1989-1994

SYNTEX HUMACAO, PUERTO RICO

Coordinated and executed product registrations, optimizations and validations. Contributed to the start up of site expansion by developing, and validating new processes utilizing new technologies (SCADA, recipe driven manufacturing processes). Contributed to the launch of a new OTC product. Main responsibility was to ensure all activities associated to the production of the registration and validation batches along with proper documentation were completed on time and in order. Delivery ahead of schedule merited the Chairman’s Recognition Award of 1993. Team member of new initiatives (High Performance Teams, Just in Time, Total Quality, Cells).

CHEMIST-INSTITUTE OF PHARMACEUTICAL SCIENCES 1988-1989

SYNTEX HUMACAO, PUERTO RICO

Developed stability indicating methods for new products. Evaluated new drug stability results. Instrumentation (HPLC, Dissolution Assay Robot).

CHEMIST 1988-1988

UNIVERSITY OF PUERTO RICO RIO PIEDRAS, PUERTO RICO

Analyzed environmental samples, compiled, and reported data. Supervised and trained other technicians. Instrumentation ( Technicon Color Analyzer, liquid Chromatography.

RESEARCH TECHNICIAN 1986-1987

UTAH WATER RESEARCH LABORATORY LOGAN, UTAH

Analyzed waste, and environmental samples, compiled, and reported data. Instrumentation (Atomic Absorption, Atomic Emission, Inductively Couple Plasma, HPLC). Developed test methods.

Awards

1993, Recipient of Syntex Chairman’s Award

Education

B.S in Chemistry and Biology; University of Puerto Rico, Rio Piedras Campus. (1986)

Chemist License #3342 (inactive).

Six credits towards Information Sciences and Technology Certificate from Penn State University

Training on: Total Quality, JIT, Conducting Audits (Pfizer Program) and Project Management (PMP, 35 hours- Pfizer program)

References

Personal and professional references are available upon request

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