Summary
Overview
Work history
Education
Skills
Certification
Languages
Timeline

Lizzette Rivera-Irizarry

Caguas,PR

Summary

Hardworking service management professional with extensive experience in area of principles and practices of regulatory compliance: Federal Drugs Administration, 21 CFR 210, 211, Part 11, Medical Devices (21 CRF 820), ISO 13485 and European Regulations, Active Pharmaceutical Ingredient, Sterile Active Pharmaceutical Ingredient, Solid Dosage and Finished Goods manufacturing process] leadership and Project Life Cycle. Skilled in business planning and organization to maintain smooth daily operations. Motivated Project Manager with six years of experience controlling all stages of projects from inception through monitoring and closing, exceeding expectations of being on time and on budget. Considerable client-facing project experience has driven commitment to customer satisfaction. Focused Project Manager adept at planning, directing and maintaining continuous operations in various departments. Experienced in directing manufacturing employees and keeping efficient production in accordance with quality standards. Applying creative and analytical approach to operations for continuous process improvement. Skilled at identifying or anticipating problems and providing solutions. Excels through mentoring, training and empowering team to excel in performance. Talented professional considered knowledgeable leader and dedicated problem solver. Brings over 22 years of valuable expertise to forward company objectives. Attentive to detail with experience in coordinating projects, programs and improvements. Determined Training Manager adept at assigning tasks to team members based on individual strengths. Communicated with key project stakeholders to ascertain project requirements. Professional Project Management Specialist with experience working with teams to accomplish short- and long-term project goals. Managed budgets and monitored project costs. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Determined Training Manager and Project Manager adept at assigning tasks to team members based on individual strengths. Communicated with key project stakeholders to ascertain project requirements. Talented professional considered knowledgeable leader and dedicated problem solver. Brings over 22 years of valuable expertise to forward company objectives. Attentive to detail with experience in coordinating projects, programs and improvements. Team leader committed to improving customer satisfaction. Skilled at policy implementation, strategic planning and staff governance. Listens to customers to understand needs and optimize service delivery.

Overview

30
30
years of professional experience
1
1
Certificate

Work history

Project Manager

Aurobindo PR
Caguas, PR
09.2020 - Current
  • Manage Engineering Department projects portfolio, business process modeling (BPM) and business value
  • Drive project portfolio, and administration to align overall project activities of cross functional teams, improve and monitor Engineering Department
  • Key Performance Indicators (KPI), Shutdown capital project, progress dashboard and weekly reports for all departments.
  • Delivered on projects' key objectives with agreed budgets, timelines and standards.
  • Adhered to project governance cadence and escalation routes.
  • Documented appropriate project plans and controls in line with change lifecycle.
  • Identified and deployed resources with individual responsibilities for project completion.
  • Assured project documentation followed internal quality standards.
  • Defined risk profiles for each project and prepared contingency plans to minimize business risk.
  • Lead and drive department governance: CAPEX projects, shutdown, Quality actions, CAPA, Change Control, Engineering investigations, Audits, events offenders, and improvements actions, among others.
  • Identified and managed budget, timescale and scope changes, recommending actions and improvements to meet project goals.
  • Acted as single point of contact for customers and internal stakeholders.
  • Prepared project performance reports with statistics and newly researched information.
  • Implemented and maintained appropriate systems to enable successful planning and scheduling.
  • Used project management tools and techniques for positive, successful outcomes.
  • Managed workforce planning, compiling information for informed decision-making.

Operational Excellence/Project Manager

Mylan LLC
Caguas, PR
10.2019 - 09.2020
  • Drove project portfolio, project life cycle, align project activities of cross functional teams, improve and monitor Key Performance Indicators (KPI).
  • Controlled resources by department or project and tracked use in Microsoft Project.
  • Led Laboratory Investigation reduction team, Hold Process Improvement team, Quality Council Improvement Metrics, to enhance customer service, cost reduction, and Quality/EHS compliance
  • Translated senior management directives into actionable front-line policies and implemented changes with staff..
  • Handled negotiations with outside vendors and service agencies to meet group needs.
  • Investigated issues affecting group operations, prepared reports and helped correct problems.
  • Drafted procedural statements and guidelines for company-wide use.
  • Streamlined processes to improve and optimize office operations.
  • Develop, mapped, re-aligned business process.
  • Conducted feasibility studies, business plan/case, project plan, business process modeling (BPM), business value and communicating them to relevant site leaders' managements.
  • Accomplishments
  • Lead and implemented following initiatives/projects: AQL Sampling reduction 58 % of Cycle Time and 82% quantity of sample), Trackwise Quality
  • Hold Process (reduction 58% records open/initiated and 27 aging open), LIMS
  • Cleaning Process Efficiency (Paperless system), Heavy Metals Test eliminations (346 HM Test reduction)
  • Laboratory Investigation Reduction Plan - Reduced 36% (122) of out of specifications events versus 2019.
  • Implemented Pilot Program to improve events majors' offenders,
  • Technical Knowledge, decision making and laboratories techniques (27 weeks without events)
  • Develop Business Case, Business Modeling Plan (BMP) Project Plan of Site Meeting and Micro Revamp.
  • Defined risk profiles for each project and prepared contingency plans to minimise business risk.
  • Delivered on projects' key objectives with agreed budgets, timelines and standards.
  • Adhered to project governance cadence and escalation routes.
  • Documented appropriate project plans and controls in line with change lifecycle.
  • Led technical delivery teams with in-depth understanding of processes and techniques to deliver high-quality solutions.
  • Used project management tools and techniques for positive, successful outcomes.
  • Prepared project performance reports with statistics and newly researched information.
  • Managed workforce planning, compiling information for informed decision-making.
  • Assured project documentation followed internal quality standards.

Quality Training Manager

Mylan LLC
Caguas, PR
08.2015 - 10.2019
  • Oversee design, development, and delivery of technical and federally required training programs for all employees
  • Maintain and administer regulations/compliance (cGMP) training program to be current as to industry trends and global regulatory expectations
  • Provide quality oversight, review and approval in design, development site on-the-job training certification program
  • Maintain and administer system to ensure accuracy and completeness of relevant GMP job descriptions
  • Supervises activities of subordinate staff.
  • Participate in development of quality improvement initiatives related to training.
  • Collaborate in develop of budget for quality training group
  • Participate in preparation, evaluation, and monitoring training metrics with executive management.
  • Promotes operational excellence projects.
  • Interact with regulatory, external, and internal auditors, as necessary
  • Ensures that area goals and objectives are accomplished
  • Develops and monitors system of performance metrics to track overall performance of area.
  • Organised delivery of specialised training in liaison with external service providers.
  • Collaborated with Subject Matter Experts (SME)s to refine and update training resources.
  • Analysed training requirements at individual, team and organisational level.
  • Formulated training and development programmes to capture measurable improvements.
  • Increased accessibility to training workshops and materials by catering to specific requests.
  • Created training programmes guaranteed to achieve key organisational objectives.
  • Engaged professionals in industry-specific knowledge, techniques and methodologies.
  • Investigated needs of and threats to organizations in various industries.
  • Produced training and supportive materials tailored to organizational needs.
  • Tracked impact of training programmes against pre-established metrics.
  • Planned training schedules, prepared materials and booked necessary rooms and facilities.
  • Implement and create training organization and programs for all site organization.
  • Accomplishments
  • Implement and create training organization and programs for all departments in Mylan.
  • Develop new training program, include improving existing ones.
  • Design CBT - Site New Hired Orientation
  • No critical or major audit observation.
  • Produced training and supportive materials tailored to organisational needs.

Training Curriculum Specialist- Contractor

Mylan LLC
Caguas, PR
03.2014 - 01.2019
  • Evaluate current training state and training quality system gaps
  • Develop design of regulatory training curriculum for each Mylan employee
  • Develop as regulatory curriculum for each area and communicate to Quality Management actifón plan and quality systems gaps.
  • Made recommendations about improvements to curricula and teaching methods to educational boards.
  • Organized school attendance at educational events and conferences to connect with potential students.
  • Analyzed quality of existing curricula, communicating with education professionals to create accurate analysis.
  • Reviewed adherence to established curriculum and communicated required changes and development.
  • Led curriculum improvement with course leaders with focus on increasing pass rate and overall performance.
  • Conducted workshops and conferences to train teachers in new programmes and teaching methods.

Technical Writer - Contractor

Merck
Las Piedras, PR
03.2013 - 11.2013
  • Gathering data of operation equipment manual and develop process and cleaning procedure for new product launch
  • Challenge and revise solid dosage procedure for compression, coating, and cleaning
  • Design and delivery training material and qualification tool procedure created or revised.
  • Contributed to technical content strategy by applying coating,granulation,compressing,packaging expertise.
  • Contributed to technical content strategy by applying granulation,compressing,packaging expertise.

Knowledge Transfer/Continuous Improvement Leader

Bristol Myers Squibb Company
Humacao, PR
04.2003 - 07.2012
  • Deliver regulatory training and Continuous Improvement tools and methodology
  • Lead, Coach and execute site improvement initiatives and make recommendations to leadership team.
  • Lead site training department including Regulatory Training Master Plan and responsible for audits and government inspections management regarding trainings.
  • Led and motivated talented project teams, achieving targets within stipulated deadlines.
  • Defined project scope, milestones and task allocation to establish and maintain clear progress plans.
  • Submitted performance feedback to stakeholders, keeping project teams on track.
  • Managed scopes and deadlines using different project management methods.
  • Led meetings with department executives to review project status, drafting action plans to deliver proposed changes.
  • Built relationships with stakeholders through outstanding client management skills.
  • Improved operations by generating project status reports and identifying issues for corrective action.
  • Trained and mentored junior team members, leveraging previous experiences in boosting project progress.
  • Reduced downtime with effective scheduling and resourcing.
  • Accomplishments
  • Reduce process cycle time and Quality Event streamline and response cycle time (less than or equal 30 days)
  • Significant reduction human error at root cause of investigation.
  • Improved standard operational procedures and manufacturing record to reduce human intervention (less than 60% intervention)
  • Reduce New Orientation from 3 days to one (1) day (from 20 to 8 hours)
  • No critical or major audit observations

Quality Assurance Auditor

Bristol Myers Squibb Company
Humacao, PR
10.1998 - 04.2003
  • Performs formal internal audits and pre-approval inspections of manufacturing, laboratory, and warehouse operations for cGMP's compliance
  • Regularly reports as necessary and follow up on observed deficiencies
  • Prepares annual product reviews report for each drug substance
  • Created audit checklist and audit plan based on assigned area, applicable regulations, and quality systems and/or procedural requirements
  • Assists regulatory section to manage and update documentation intended for regulatory agencies, such as master files, new product registration, supplements submissions, and foreign country registrations, among others
  • Managed regulatory inspections, auditing quality systems and processes used in manufacturing product, CAPA system and root cause analysis to be following regulatory and quality standards
  • Investigates customer complaints, issues corresponding report indicating cause and recommending solutions
  • Write reports of audit results to responsible management
  • Accomplishments
  • No critical or major audit observations
  • The 100 % of internal and external audits performed as per schedule
  • Closed corrective and preventive actions before time required.
  • Submitted performance reports, identifying shortfalls and facilitating improvement actions.
  • Created and issued Standard Operating Procedures for team members to follow.
  • Measured and monitored quality performance against agreed KPIs, implementing recommendations.

Product Compliance Specialist

Bristol-Myers Squibb
Humacao, PR
01.1993 - 10.1998
  • Audits manufacturing and QC laboratory documentation, vendor certificates and receiving reports for completeness and compliance with company and GMP requirements.
  • Installed internal controls and set up standard procedures for business accounting systems.

Education

Bachelor of Science - Chemistry

University of Puerto Rico, Cayey
1989

Skills

  • SKILLS
  • Team Bonding
  • Strategic planning
  • Functional & Business Requirements
  • Performance Evaluations
  • Change Control Processes
  • Project Management
  • Staff Management
  • Excellent writing and verbal communication
  • Bilingual
  • Able to work under pressure
  • Computer literate
  • Interdisciplinary collaboration
  • Project planning and development
  • Advanced problem solving
  • Lean manufacturing and design
  • Procedure development
  • Hiring and training
  • Compliance understanding

Certification

CRF 820), ISO 13485 and European Regulations, Active Pharmaceutical Ingredient, Sterile Active Pharmaceutical Ingredient, Solid Dosage and Finished Goods manufacturing process. Lead and Coach Continuous Improvement and site projects initiatives. (Cycle Time Reduction, Quality Events Streamline and Cycle Time, Process Map, Effective Job Function Training, FDA remediation, annual shutdown, Quality Investigation reduction, Key Performance Indicators improvements and Engineering Governance Management, process change and Project Portfolio). needed for the proper transfer of operations knowledge to our personnel in regulatory and non-regulatory training programs. ASQ Certified Six Sigma Green Belt and Project Management Course.

Languages

English
Upper intermediate

Timeline

Project Manager - Aurobindo PR
09.2020 - Current
Operational Excellence/Project Manager - Mylan LLC
10.2019 - 09.2020
Quality Training Manager - Mylan LLC
08.2015 - 10.2019
Training Curriculum Specialist- Contractor - Mylan LLC
03.2014 - 01.2019
Technical Writer - Contractor - Merck
03.2013 - 11.2013
Knowledge Transfer/Continuous Improvement Leader - Bristol Myers Squibb Company
04.2003 - 07.2012
Quality Assurance Auditor - Bristol Myers Squibb Company
10.1998 - 04.2003
Product Compliance Specialist - Bristol-Myers Squibb
01.1993 - 10.1998
University of Puerto Rico - Bachelor of Science, Chemistry
Lizzette Rivera-Irizarry