Validation Manager Quality Assurance Manager

Summary of Qualifications

Accomplished, innovative, and detail-oriented professional, offering progressive background and proven expertise in pharmaceutical validation, project management, and quality assurance operations within the cGMP-regulated environment.

Adept at leading commissioning, qualification, and validation of facilities and utilities, production equipment, laboratory equipment, software, cleaning, and computer systems in compliance with validation master plan, regulatory requirements, and site-specific policies and procedures.

Skilled at reengineering unproductive work processes as well as planning and implementing various sustainable and cost-effective programs to drive continuous improvement of operations.

Equipped with excellent problem-solving and interpersonal aptitudes; effective at collaborating with and motivating staff to achieve optimal output rates, while maintaining safety methods and practices.

Proficient with Microsoft Office Suite (Word, Excel, and PowerPoint) and Microsoft Project.

Core Competencies

cGMP Regulation Compliance Commissioning and Qualification Software Life Cycle

Electronic Records and Electronic Signatures Data Integrity Resource Allocation Project Management

Performance Monitoring Staff Supervision and Training Continuous Improvement

Professional Experience

Recro Pharma, Gainesville, GA, USA

Validation Manager 2018–Present

Oversee validation activities for two sites that involve equipment, process, automation/computer systems, and cleaning validation and reporting of activities in accordance with corporate, business unit, and site policy and procedures

Supervise the Validation Planning Committee to ensure maintenance of validation project plans by defining priorities

Provide training, counseling, and mentorship to validation staff, while setting up group goals and guiding staff toward implementation of goals

Direct and maintain coordination with consulting staff to guarantee adherence of projects to company policies

Demonstrate broad understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, process, computer systems, and cleaning validation

Formulate a strategy in performing validation projects, and spearhead the site’s risk assessment program

Take part in regulatory and client audits on all validation-related queries

Offer hands-on support to validation staff to each of the IT Committees to ensure maintenance of all systems as well as data integrity

Efficiently managed the validation program for the new Recro Gainesville Development (RGD) facility through execution of procedures and templates using phase-appropriate approach which increased cGMP expectations, while maintaining consistency and compliance throughout the validation life cycle

Validation Engineer III 2016–2018

Rendered technical assistance to validation group in the areas of automation, equipment, laboratory, and computer systems

Administered validation requirements, protocols preparation, 21 CFR Part 11, risk assessment, and related documentation regarding validation lifecycle

Assumed accountability in analyzing and approving qualification protocols, risk assessments, deviations, Corrective and preventive action (CAPAs), user requirements, and functional/design specifications

Took full charge of drafting validation documents, defining qualification strategies, and presenting and negotiating path forward with approvers

Reviewed and modified internal procedures to meet CAPAs and commitments, while maintaining alignment of procedures with regulatory agencies expectations and company practices

Served as a validation representative for process control, laboratory, manufacturing equipment, and quality assurance (QA) software steering committees

Arranged recurrent meetings to discuss project status, determine and eliminate roadblocks, and present project visibility to shareholders

Fulfilled other tasks such as defining validation strategies, creating validation plan and protocols, and working closely with IT and manufacturing personnel for protocol execution

Functioned as validation project manager for the Glatt 3 control system implementation and upgrade that included identifying validation activities, roles, and responsibilities as well as organizing project schedule and validation plan

Drove efforts in successfully completing the serialization project in compliance with the Drug Supply Chain Security Act (DSCSA) and Food and Drug Administration (FDA) deadlines

Therapeutic Proteins International, LLC, Chicago, IL, USA

Senior Validation Engineer 2013–2016

Designed plan schedules and resource plan, delegated tasks, and monitored activities to ensure completion of project within allotted time and budget

Effectively guided contract and regular validation employees and assisted the validation personnel in the areas of computer, equipment, utility, and facility qualifications

Performed a key role in selecting, interviewing, and contracting resources in support of validation activities

Exemplified skills in analyzing and approving qualification protocols for laboratory equipment, temperature chambers, manufacturing equipment, facility, and utilities such as compress air, nitrogen, and water distribution system

Coordinated with QA in reviewing strategies and agreements

Managed and maintained qualification completion of bulk drug substance suites, bulk drug product suites, and related equipment in nine months for a small size biosimilar facility

Made major contribution in accomplishing qualification of a new bulk drug product suite and related equipment in six months that improved manufacturing capacity

Pioneered the implementation and qualification of a centralized monitoring system

Abbott Biotechnology, LTD, Barceloneta, Puerto Rico

Senior Validation Engineer – AbbVie, LTD 2004–2013

Ensured alignment of the ABL validation program with the divisional policies and regulatory expectations

Administered the change control program for the validated/qualified systems to maximize their capability to meet quality requirements and good manufacturing practices (GMP)

Executed the annual update of the validation master plan, and acted as Validation Review Board member in charge of producing QA review and approval of validation documentation

Keenly examined factory acceptance testing, site acceptance testing, commissioning, technical reports, engineering studies, regression testing, and test protocols

Presided over the training of staff on good documentation practices (GDP), validation requirements, validation management system, and change control program

Acted as part of a global team in the verification, acceptance, implementation, and validation of the syringe filling line

Led the development and approval of design qualification documents, commissioning and qualification plans, and audit commissioning/validation protocols

Earned an award for outstanding performance and contribution to the ABL Pre Approval Inspection (PAI) readiness and FDA inspection approval

Succeeded in establishing the Cleaning Validation Program that involved formulating program strategy, preparing budget, and generating headcount requirements with 10 contract employees and a budget of $1.2M

Received recognition for the Manufacturing Execution System (MES) plant-wide implementation of the cleaning and steam in place critical parameters that removed paper-based records

Achieved an award for major contribution during the small volume parenteral (SVP) filling line as part of the Puerto Rico Factory Acceptance Test Team

Earlier Career

Abbott Fermentation Products of Puerto Rico, Inc. (formerly Abbott Chemical Plant, Inc.), Barceloneta, Puerto Rico

Quality Assurance Project Leader

Senior Validation Engineer

Abbott Chemical Plant, Inc., Barceloneta, Puerto Rico

Senior Validation Engineer

Process Control Engineer

Validation Engineer

Education

Master of Engineering in Management Systems Engineering

University of Puerto Rico, Mayagüez Campus, Mayagüez, Puerto Rico

Bachelor of Science in Electrical Engineering

University of Puerto Rico, Mayagüez Campus, Mayagüez, Puerto Rico

Professional Development

Training/Courses:

-Leadership Boot Camp and Performance Coaching by Academy Leadership Franchise

-Situational Leadership

-Facilitating Skills

-Facilitating Interactive Training

-Project Management Fundamentals

-ISPE GAMP Data Integrity 21 CFR Part 11 Training Course

-Computer System Validation Boot Camp by Praxis Life Sciences

-ISPE A Risk-based Approach to Compliant Electronic Records and Electronic Signatures

-Software Development Life Cycle

-Effective Root Cause Analysis

-Six Sigma Black Belt Methodologies

-Veeva Vault Administration Training

-IVT Cleaning Validation

-Microbiology for Non-microbiologists

Certification:

-Certified Veeva Administrator

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