CAREER PROFILE:

• Over 30 years experience in the Pharmaceutical Industry applying knowledge in GMP practices and FDA/European regulations at different areas such as Manufacturing Area Investigations, Engineering Quality Compliance, Quality Assurance, Aseptic Area Manufacturing, Training, Safety, Environmental Compliance, and Purified Water Systems.
• Experience with solid dose, aseptic filling and medical device processes investigations writing and evaluation and advance word, excel and power point experience.
• Certified Operational Excellence (Six - Sigma) Green Belt, Six-Sigma Advocate, Working Words, Organizational Trainer, TrackWise and SAP. Have ability to set goals, prioritize work, remain on target and perform well under stressful circumstances. Good interpersonal relationships.
• Have participated in projects where a deep knowledge of cGMPs and regulatory agencies (FDA, EMA, MHRA) requirements is necessary such as:
• Product transfer of contract manufacturing product.
• Redesigning and simplifying MBR and SOPs for clients that were under consent decrees and with an outstanding record of achievements and commitment to quality.
• Perform manufacturing process investigations and CAPAs under tight schedule due dates and high complexity diversity workplace environment.
• Support validation process for product, equipment, process changes and systems to conform to the latest applicable cGMP guidelines and company objective and resources.
• Prepare Demo, Registration, Holding Time Study and Process Validation protocols and reports.
• Prepare Standard Operating Procedures (writing, evaluation and approval) from an Engineering Area point of view and site wide.
• Perform proactive actions to improve Investigations Team performance and reduce investigation process cycle time to improve investigations reports quality by ensuring right first time (RFT) investigation reports. Maintain policies, guidelines and systems to ensure compliance.
• Participate in regulatory agencies inspections and audits.
• Manage the Quality Improvement program for a site’s Engineering Area, providing assessment on all regulatory compliance related activities to ensure and improve compliance with regulatory requirements.
• Develop, coordinate, and conduct self - compliance audit program, answer internal compliance audits and compliance reports, and communicate results to Engineering Area Management

SPECIAL SKILLS:

Languages: Fluent in written and spoken English and Spanish plus basic knowledge of Italian.

Trainings and Certifications: Certified Operational Excellence (six-sigma) Green Belt, Six-Sigma Advocate, Working Words, Organizational Trainer and SAP maintenance module. Statistical Process Control, Just-In-Time, and Crosby's Quality Platform techniques.

Computer Programs: Personal Computer Operation and Software (TrackWise, Enovia, Windows, Office (Word, Power Point, and Excel), Internet, Outlook, Lotus Notes e-mail, Adobe Photoshop, multimedia, AS/400, etc.

Technical Writing and Investigations: Firsthand experience with third party interaction. Excellent investigation and technical writing skills for solid dose, aseptic filling and medical device processes with outstanding evaluation appraisal by third party and contract clients. Deep knowledge of FDA, EMA, MHRA, OSHA, etc. requirements. Excellent in applying analytical thinking into troubleshooting and process improvements with proved results.

PROFESSIONAL EXPERIENCE:

Confidential, San Juan, PR

Technical Writer

Responsibilities:

• To perform manufacturing process (solid dose) deviation investigations and CAPA resolution documenting and reporting using the TrackWise-CAPA System application.
• Support the process deviations investigations for Manufacturing Areas.
• Support the QA Complaints Area in process related complaint investigations.
• Participate in multi-disciplinary group dynamics to determining root cause and to establish CAPAs to correct and prevent incidents reoccurrence.

Confidential, Caguas, PR

Sr. SCIENTIST RESOURCE

Responsibilities:

• Assist Confidential validation team in the performance of Cleaning Validation for their new Confidential ® manufacturing facilities at AML-6 building.
• This assignment requires writing protocols for cleaning, sampling and testing and the execution of the cleaning validation activities to validate the cleaning process for the biotechnology manufacturing equipment such as baseline visual inspections, visual inspections, surface and rinse water sampling and environmental sampling.

Confidential, San Juan, PR

QA INVESTIGATION SPECIALIST

Responsibilities:

• Assist Confidential QA management in the evaluation and approval of manufacturing process deviations, investigations, and CAPAs using the TrackWise documentation system.
• Ensure that all quality issues related to manufacturing processes are performed in accordance with the applicable regulations and determine whether the events impacted the safety, identity, quality, and purity of the implicated product and if the necessary measures and actions taken to prevent reoccurrence have been satisfactory prior to product release in accordance with Current Good Manufacturing Practices (cGMPs).
• Assist production staff with the resolution of production events from a regulatory standpoint.
• Perform QA Investigations Annual Product Review.
• Procedures Gap Analysis.
• Assisted Meridian Medical Technologies management in the resolution of aseptic process deviations, investigations, and CAPAs via TrackWise system.
• Lead the resolution of deviations, investigations and CAPAs, from beginning to end.
• During this assignment over 50 pending and new CAPAs were closed on time per established procedures with reduced cycle time from 30 to 90 days or more to 1 or 2 weeks (about 20 days in average).

Confidential, Guaynabo, PR

CAPA SPECIALIST

Responsibilities:

• Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments.
• Served as liaison between project team and department.
• Managed all aspects of projects (planning, implementation, monitoring, completion and follow-up. Manage competing timelines and prioritize critical tasks.
• Established and achieved project standards for work quality and quantity.
• Assessed project issues and developed solutions to meet specific productivity, quality and client satisfaction goals and objectives.
• Assisted in technical, financial and organizational issues by researching issues, providing recommendations and maintaining document archives.

Confidential, Caguas, PR

MANUFACTURING SPECIALIST

Responsibilities:

• Following corporate Guidelines and Industry Standards (in compliance with the FDA, EMEA, JMHW, GAMP, ISO and ISPE), supported the Technical Services area manufacturing activities in Validation, Periodic Review of Manufacturing Validated Equipment, Process Investigations and Product Transfer activities.
• The tasks assigned as contract support include, but were not limited to:
• Completed the product transfer of contract manufacturing product:
• Write/review protocols and Master Batch Records for placebo, demo batches, registration batches, Holding Time Study and Process Validation.
• Execute/supervise/troubleshoot the transfer activities including but not limited product manufacturing stages from Blend through Encapsulation
• Investigate and write CAPA reports for all discrepancies and protocol deviations encountered throughout the transfer process for each stage as applicable and report in TrackWise system.
• Write/review all the reports for the placebo, demo batches, registration batches and Holding Time Study as applicable
• Performed Equipment IQ/OQ to new manufacturing equipment.
• Executed process investigations (CAPA) for different manufacturing related events including manufacturing deviations and complaints.
• Performed the Periodic Review Reports for the Neolpharma-Caguas, to establish equipment in-control status and/or pending issues that impact the validated status of the equipment and its resolutions.
• Reviewed and updated of the Periodic Review of Manufacturing Validated Equipment procedure to make it more agile assuring compliance.
• Tracked compliance documentation status through current available tools, including project metrics, schedule control, and document routing and approval.

Confidential, Guaynabo, PR

MANUFACTURING SPECIALIST

Responsibilities:

• Supported the execution of manufacturing/quality systems such as non - conformances, process validation, procedures, training, and new product introduction. Applied process, operational, scientific expertise, basic compliance knowledge and analytical and troubleshooting skills to support the manufacturing operations.
• Served as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Initiate, revise and approve manufacturing procedures. Ensure all procedures reflect current operations.
• Provided assistance in the generation of training materials related to the scientific and technical aspects of the process. Supported the process to establish process-monitoring parameters and control limits. Collected process-monitoring d Confidential and supported the assessment of deviations. Provided support for the timely execution of the process monitoring quarterly reports.
• Managed NC/CAPA closure using Track Wise system within the established goal date to support manufacturing activities and ensure fulfillment with established product release. Serve as a document owner to ensure that all Non-conformances were triaged within the established goal. Reviewed equipment/system Root Cause Analysis investigations and support trend evaluations. Monitored and communicate incidents trends.
• Provided support for the generation of process validation protocols and reports and execution of process validations and the collection and analysis of process validation d Confidential .
• Participated in the NPI process assessing the requirements for documentation, materials, training, and equipment modifications as applicable. Assessed, prioritized, justified and provided implementation and project management support for process and equipment modification projects.
• Assisted the Manufacturing Change owner with CCRB packages affecting the manufacturing process.

Confidential, Guaynabo, PR

CAPA LEADER

Responsibilities:

• Performed manufacturing process (solid dose) deviation investigations and CAPA resolution documenting and reporting using the TrackWise - CAPA System application.
• Supported the process deviations investigations for Manufacturing Areas.
• Supported the QA Complaints Area in process related complaint investigations.
• Participated in multi-disciplinary group dynamics to determining root cause and to establish CAPAs to correct and prevent incidents reoccurrence.
• Performed final batch quality assessment evaluation for batches release.

Confidential, Guaynabo, PR

CAPA LEADER

Responsibilities:

• Performed manufacturing process (solid dose) deviation investigations and provided technical writing to Confidential Consumer Health plant in Guayama, PR. This assignment required to perform the following tasks among others:
• Perform process deviations investigations for Manufacturing Areas (solid dose and packaging).
• Assembled multi - disciplinary group to perform root cause analysis and establishing CAPAs to correct and prevent incidents reoccurrence.
• Reported and documented event and investigation reports using the SAP-CAPA System application and TrackWise software applications.

Confidential, Dorado, PR

TECHNICAL WRITER / QUALITY ENGINEER / VALIDATION SPECIALIST

Responsibilities:

• Work performed specifics include (among others):
• Provided professional consultation on medical devices, pharmaceutical and cGMP requirements
• Responded to Corporate Quality Audit items.
• Performed QA Complaints Area in investigations.
• Performed assessment on validation, quality, facilities and utilities improvements to upgrade plant to FDA 820 Medical Devices Class 1
• Executed CSV to stand alone PLC based machine control and touch screen panels
• Wrote protocol, executed process validation and final reporting for blister packaging line

Confidential, Dorado, PR

VALIDATION SPECIALIST/QUALITY ENGINEER

Responsibilities:

• Performed cleaning equipment evaluations to improve cleaning process and ensure compliance with FDA requirementsDeveloped qualification requirements for facilities and utilities
• Provided professional consultation on medical devices, pharmaceutical and cGMP requirements.
• Prepared the Validation Program SOP
• Prepared the Utilities Validation SOP
• Response to Corporate Quality Audit items
• Assessment on validation, quality, complaints investigations, facilities and utilities improvements to upgrade plant to FDA 820 Class 1 Medical Devices

Confidential, Manatí, PR

SENIOR CONSULTANT

Responsibilities:

• Perform SOPs assessment to improve performance and ensure compliance of a pharmaceutical company’s microbiology laboratory.
• Prepared reports on findings, regulatory issues and improvement opportunities.
• Interview site’s personnel to establish SOPs accuracy and detect gaps between written instructions and actual practice
• Evaluated and established procedures and documentation forms correlations to ensure system uniformity for the microbiology area
• Participated at the project team meetings and brain storming sessions to ensure holistic compliance with client’s deliverable requirements and regulatory issues

Confidential, Cidra, PR

INCIDENT ANALYST

Responsibilities:

• Developed and documented Investigation Plans in alignment with the event level, type and complexity.
• Performed process deviations investigations for Manufacturing, Engineering and Complaints Areas.
• Assembled multi-disciplinary group to perform brain storming for root cause analysis, coordination of corrective actions, establish Corrective and Preventive Actions (CAPAs) to eliminate deviations, correct and prevent incidents reoccurrence, and monitor quality results.
• Reported and documented incident and investigation reports in TrackWise System.
• Performed proactive actions to improve Investigations Team performance and reduce investigation process cycle time to improve investigations reports quality by ensuring right first time (RFT) investigation reports.

Confidential, PR

ENGINEERING QUALITY IMPROVER

Responsibilities:

• Managed the Quality Improvement program for the site’s Engineering Area by providing assessment on all regulatory compliance related activities and developing mechanisms and actions to ensure compliance. Follow up and coordinated the resolution of corrective actions to improve quality issues. Developed and lead quality improvement projects aimed at reducing costs and waste.
• Identified and implemented preventive and corrective (CAPAs) initiatives within the Engineering Area to achieve the Total Quality process goal.
• Performed all the Engineering Area incident and investigation reports
• Develop, coordinate, and conduct self - compliance audit program, answer internal compliance audits and compliant reports, to communicate results to Engineering Area Management and establish actions to ensure compliance.
• Maintained policies, guidelines and systems to ensure the Engineering Area’s compliance with the corporate policies and procedures, and Local and Federal Regulations (CGMP, FDA, DEA and OSHA)
• Support the validation process for product, equipment, process changes and systems to conform to the latest applicable cGMP guidelines and company objective and resources.
• Engineering Area and site Standard Operating Procedures writing, evaluation, and approval from engineering area standpoint.
• Participate in regulatory agencies inspections and audits.
• Perform the evaluation of the Global Business Processes System (GBPs) and site Safety and Environmental SOPs integration into the SAP infrastructure.
• Indicate and validate that the site’s safety and environmental requirements, compliance activities and accident prevention instructions for the maintenance and other routine activities were in conformance with established procedures and regulatory requirements. This was required to establish the safety requirements for all the site machinery and equipment subjected to maintenance and repair intervention under the SAP platform.

Confidential, Cidra, PR

INDUSTRIAL HYGIENIST

Responsibilities:

• Manage and perform the site’s chemical safety related activities and programs such as management of the site’s Hazard Communications
• Program including MSDS master file maintenance, manufacturing areas MSDS files auditing and training.
• Perform all the site’s chemical risks assessments for existing and new products or materials, Industrial Hygiene Monitoring Studies and Reports for the entire site. I.H. studies include air sampling (particulate, gases), and noise surveys and dosimetry studies.
• Provide short and long-term solutions for the deficiencies and/or risks detected based on studies findings and d Confidential evaluation.

Confidential, Cidra, PR

SAFETY SPECIALIST

Responsibilities:

• Perform hazards assessment for the different tasks and working areas (change and improvements proposals, and new chemical products).
• Update and review safety related procedures as well as standard operating procedures.
• Develop and perform all the required safety compliance training. Investigate and provide ways to eliminate reoccurrence of accidents and incidents.
• Perform Industrial Hygiene studies to establish required respiratory protection equipment and engineering controls.
• Issuing confined spaces entry permits and administration of the program for the assigned areas.

Confidential, Cidra, PR

TRAINING COORDINATOR

Responsibilities:

• Coordination of the Flexible Work Force training effort and activities for the Engineering Utilities, Tablets and Sterile manufacturing areas.
• Training system develop and improvement
• Writing and updating of technical training modules
• Recording of audio and video training modules
• Training sessions to the Engineering Area technicians