César A. Bermúdez
Barceloneta
Summary
Manufacturing and Packaging Supervisor with vast experience within the Medical Devices and Pharmaceutical Industries. Knowledge of production specification, critical success factor, financial Capacity Planning, budgeting and Capital expenditure (CER) preparation. Knowledge of ISO 9000, OSHA and GMP standards compliance. Computer literate. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
46
46
years of professional experience
Work History
Process Improvement and Investigations
PuraCap Pharmaceutical, LLC
01.2022 - Current
- Currently performing NOE’s notifications, investigations of Notice Of Events in the manufacturing/packaging area
- Based on the event, defining the problem or opportunity, collecting data, analyzing the data, identifying potential solutions and implementing them, and controlling and evaluating changes.
- Collaborated with organizational stakeholders to align process improvement initiatives with strategic objectives.
- Gathered input from employees at all levels of the organization to gain a comprehensive understanding of existing problems.
- CAPA implementations and closure.
- Revision of SOP's and Batch Records as required.
Packaging Supervisor
PuraCap Pharmaceutical, LLC
01.2016 - 01.2022
- Oversee daily packaging activities and scheduling within the manufacturing department
- Assist in the development and planning of all long-term packaging strategies and schedules to ensure the timely and efficient operation of the packaging department
- Contribution with troubleshooting daily operational/technical scheduling issues to accomplish short- and long-term packaging objectives
- Support liaison activities for the division with respect to technical, operational and scheduling issues with suppliers.
Manager Support - Receiving
Sam’s Club
01.2010 - 01.2014
- Responsible for overseeing the receiving of all merchandise and perishables in the store, coordinate the work shifts of all associates and assigned required tasks
- Assure compliance of procedures to maintain inventory control, assist managers in Claims and UPC
- Improved receiving time of merchandise by associates implementing daily goals
- Supervised one Supervisor, two clerks and four associates.
Packaging Supervisor
Biovail Laboratories LLC
01.2002 - 01.2009
- Guided the Packaging Department which included 27 employees
- In charge of coordinating and implementing packaging activities in accordance with current cGMP
- Assist in the development of packaging strategies to comply with Logistics plan schedule
- Participate in the hiring and selection of packaging production personnel
- Assist in preparation of department budgets related to packaging activities.
- Selected Accomplishment:
- Improved 101% the packaging and manufacturing attainment to plan by providing specific itineraries which establish a fast-working pace and also reduced overall packaging change over time.
- Successfully achieved zero critical observations during all the regulatory audits because of the training provided to the employees with special emphasis on operational procedures
- Also established daily audits as a preventive action plan.
Packaging Supervisor
Tyco Health Care Group (USS – Davis & Geck Ltd.)
01.1979 - 01.2002
- Supervised Packaging operations while interacting with the warehouse operations to ensure the on-time delivery of finished goods to the distribution center
- Generated and reviewed all packaging related SOP’s and Job Hazard Analysis
- Responsible for ensuring compliance with FDA and OSHA regulations
- Directly supervised 25 employees.
Senior Warehouse Supervisor
Tyco Health Care Group (USS – Davis & Geck Ltd.)
01.2000 - 01.2001
- Temporary Assignment in San Isidro Manufacturing Site, Santo Domingo, Dominican Republic
- Selected to organize the startup process for the San Isidro Manufacturing Site facilities in the Dominican Republic
- Coordinated the training for employees regarding GMP’s and safety practices
- Implemented the training of the SAP module for warehouse
- Prepared Standard Operating Procedures and Job Hazard Analysis for warehouse, Supervised the staging and dispatching areas of manufacturing components
- Coordinated the tracking process to reduce back orders Directed two supervisors and 26 regular employees.
Manufacturing Supervisor, Clean Room
Tyco Health Care Group (USS – Davis & Geck Ltd.)
01.1981 - 01.2000
- Supervised the 24-hour sterilization process (ETO and Gamma Radiation) in the Clean Room
- Responsible for all procedures in the Packaging Area
- Established and implemented standard operating procedures and Job Hazard Analysis
- Interface with TUV, FDA and OSHA inspectors and representatives to ensure compliance with all Federal and ISO GMP practices
- Supervised 14 employees.
- Selected Accomplishment:
- Improved the packaging process in the clean room by promoting the cell concept and assigning specific responsibilities and tasks to each group
- Reduced quality control sampling by 8% which resulted in savings of $25K
- Revised and improved SOP and manufacturing practices that resulted in the harmonization of Manufacturing and Clean Room procedures and the improvement of the overall task time
- Successfully reduced the equipment downtime by acquiring new measuring equipment for the clean room.
Education
Master - Business Administration, Supply Chain Management and Logistics
Universidad Ana G. Mendez
2021
Master - Business Administration, Management
Universidad del Turabo
1990
Bachelor’s degree - Biology/Chemistry
Catholic University of Puerto Rico
1979
Skills
- Operational Excellence
- Coaching and Mentoring
- Customer Focus
- Process Documentation
- Process improvement solutions
- Training employees
Languages
Spanish
Native language
English
Proficient
C2
Timeline
Process Improvement and Investigations
PuraCap Pharmaceutical, LLC
01.2022 - Current
Packaging Supervisor
PuraCap Pharmaceutical, LLC
01.2016 - 01.2022
Manager Support - Receiving
Sam’s Club
01.2010 - 01.2014
Packaging Supervisor
Biovail Laboratories LLC
01.2002 - 01.2009
Senior Warehouse Supervisor
Tyco Health Care Group (USS – Davis & Geck Ltd.)
01.2000 - 01.2001
Manufacturing Supervisor, Clean Room
Tyco Health Care Group (USS – Davis & Geck Ltd.)
01.1981 - 01.2000
Packaging Supervisor
Tyco Health Care Group (USS – Davis & Geck Ltd.)
01.1979 - 01.2002
Master - Business Administration, Supply Chain Management and Logistics
Universidad Ana G. Mendez
Master - Business Administration, Management
Universidad del Turabo
Bachelor’s degree - Biology/Chemistry
Catholic University of Puerto Rico
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