Pedro Perez

PEDRO PEREZ LOPEZ Hc-01 Box 11528, Carolina, PR 00987
mobile: (787) 448-5169 or 787 648-2959
email: perezpe17@gmail.com
SUMMARY OF QUALIFICATIONS
Qualified professional leader with more than 23 years of experience in the Pharmaceutical Operation with
valuable knowledge and skills in lean production principles; who has demonstrated the capacity to maintain
operations within and above all quality, safety and environmental standards while complying with internal
financial targets and defined customer service levels. SAP super user for the Manufacturing and Packaging
areas. Strong technical expertise on process and equipment used for the manufacturing on oral doses form
such as: material dispensing, granulation, tablet press machines, coating process and packaging. Well
experience as operational tour guide during the regulatory inspections. Bilingual, fluent in both English and
Spanish.
PROFESSIONAL EXPERIENCE
MERCK SHARP & DOHME INTL GMBH (PR BRANCH) LLC, Las Piedras, Puerto Rico
Process Steward PE/MH & Learning Team Lead March 2015 - Present
 Site process and MH SAP lead
 Maintain updated appropriate site SOP's maintaining process documentation and deliver
training, as required, as per COMET program.
 Ensures compliance to COMET global SOP's, as appropriate.
 Deliver SAP end-user training.
 Participate in regional meetings and internal/external communities of practices.
 Leads site meetings to ensure timely completion of changes (including master data changes)
according to business needs, decision making.
 Supports the introduction of new products and in-line extensions by assuring that all
required documentation and SAP system is correctly managed and updated in order to
comply with market requirements.
 Applies Lean Six Sigma principles and enterprise process management to solve problems
and development of process designs according to COMET design.
 Executes testing for new COMET releases and deploys/implements Production Execution,
Material Management and Inventory Management functionalities to maximize the use of
SAP at site level, as needed.
 Perform other assignments and duties as required.
 Comply with all GMP, Trade, SOX and Environmental Health and Safety regulations.
 Responsible for ensuring compliance posture related to Training. Accountable for ensuring
metrics update related to training and discussion in the Site Compliance Council.
 Supervise the training team within the Operations IPT.
 Responsible for the Training and Personnel QMS subsystem.

mobile: (787) 448-5169 or 787 648-2959
MERCK SHARP & DOHME INTL GMBH (PR BRANCH) LLC, Las Piedras, Puerto Rico
Associated Director (IPT Leader) Agosto 2012-2015
Duties:
 Lead a team of 3 supervisors and 15 operators to perform the manufacturing.
 Assure that for the recruitment and training of all the personnel were properly execute as company
guide lines.
 Responsible for all aspects of tableting & capsule manufacturing, packaging, schedule adherence,
safety, environmental, right first time and productivity metrics.
 Responsible to assure that direct report personnel has their developmental plan program, also
operators understand departmental objectives.
 Participate on the development of plant performance metrics goal for productivity, Quality and
safety areas.
 Participate in daily TIERs meetings which include discuss manufacturing quality events, metrics,
supply, safety, and task assigned.
 Development improvement plans on areas that need improvement
 Approve the validation activities reports such as: cleaning and process validation protocols, automated
systems performance monitoring and reports in agreement with Company Procedures, cGMP and
FDA requirements.
 Assure that strategies and resources to meet the schedule and production goals, raise any potential
issue that can affect the areas performance
 Responsible for atypical investigation’s activities that start during the shift in which they occur.
Approve atypical investigations or escalate them to the Process Leader, as needed. Approve the
investigation/analysis and resolution/action taken sections of the Test Incident Problem Report, as
needed.
 Assure that all the area GMP documents were aligned to process and/or batch records to assure
product quality and productivity.
 Support the Maintenance Department in the area equipment and instrumentation Preventive
Maintenance Program
 Responsible for all manufacturing process for tableting, Capsule and packaging areas: dispensing,
Granulation (Wet/Dry, Niro Fielders, top spray), Drying (Glatts), Compressing (Courtoy, Elizabeth-
Hata, FETTE), tablet coating (Glatt and Vector Coaters), Glatt wurster columns and packaging
equipment.
 Responsible for the maintenance and performance of the computer system.
 Evaluate and review change control documentation packages.
 Coordinated manufacturing and packaging schedules with for the area.

mobile: (787) 448-5169 or 787 648-2959
MERCK SHARP & DOHME INTL GMBH (PR BRANCH) LLC, Arecibo, Puerto Rico
Manufacturing Manager April 2001-2012
Duties:
 Lead a team of 6 supervisors, 4 technical support and 75 operators to perform the manufacturing and
packaging activities in 7 day/3 shift operation
 Assure that for the recruitment and training of all the personnel were properly execute as company
guidelines.
 Responsible for all aspects of tableting & capsule manufacturing, packaging, schedule adherence,
safety, environmental, right first time and productivity metrics.
 Responsible to assure that direct report personnel has their developmental plan program, also that
operators understand departmental objectives.
 Participate on the development of plant performance metrics goal for productivity, Quality and
safety areas.
 Development improvement plans on areas that need improvement.
 Approve the validation activities reports such as: cleaning and process validation protocols, automated
FDA requirements.
 Assure that strategies and resources meet the schedule and production goals, raise any potential issue
that can affect the areas performance.
Maintenance Program.
 Responsible for all manufacturing process for tableting, Capsule and packaging areas: dispensing,
Granulation (Wet/Dry, Niro Fielders, top spray), Drying (Glatts), Compressing (Courtoy, Elizabeth-
Hata, FETTE), tablet coating (Glatt and Vector Coaters), Glatt wurster columns and packaging
equipment.
 Coordinate manufacturing and packaging schedules for the areas.
 Participate in Emergency Response responsibilities

mobile: (787) 448-5169 or 787 648-2959
MERCK SHARP & DOHME INTL GMBH (PR BRANCH) LLC, Arecibo, Puerto Rico
Process Head April 2000-2001
Duties:
 Lead a team of 4 supervisors and 40 operators to perform the manufacturing activities in 7 day/3
shift operation
 Responsible for the recruitment and training of supervisor and operators
 Responsible for all aspects of tableting manufacturing, schedule adherence, safety, environmental,
right first time and productivity metrics.
 Responsible to assure that the supervisor has their developmental plan program, also operators
understand departmental objectives.
 Participate on the development of department performance metrics goal for productivity, Quality
and safety areas.
 Development improvement plan on areas that need improvement
 Support the development and execution of cleaning and process validation protocols, automated
FDA requirements.
 Support strategies and resources to meet the schedule and production goals, raise any potential issue
that can affect the area performance
Maintenance Program
 Responsible for all manufacturing process for tableting areas: Wheightment, Granulation (Wet/Dry,
Niro Fielders, top spray), Drying (Glatts), Compressing (Courtoy and Elizabeth-Hata) and tablet
coating (Glatt and Vector Coaters).
 Prepare manufacturing schedules for the area.

mobile: (787) 448-5169 or 787 648-2959
MERCK SHARP & DOHME INTL GMBH (PR BRANCH) LLC, ARECIBO, Puerto Rico
Manufacturing Supervisor May 1996-2000
Duties:
 Responsible of leading a team of 25 Manufacturing operators.
 Responsible for all aspects of tableting manufacturing, schedule adherence, safety, environmental,
right first time and productivity metrics.
 Responsible to assure that the operators understand departmental objectives.
 Participate in daily TIERs meetings which include discuss manufacturing events, metrics, supply,
safety, and task assigned.
 Support the development and execution of cleaning and process validation protocols and reports in
agreement with Company Procedures, cGMP and FDA requirements.
 Support strategies and resources to meet the schedule and production goals
 Implement changes to process and/or batch records to assure product quality and productivity.
 Support the Maintenance Department in the area equipment and instrumentation PM’s.
 Assure 100% Environmental and Safety Program compliance.
 Responsible for the area performance; product quality, complete manufacturing events reports and
correctives actions (CAPA) implementation.
 Participation in internal and external audits and inspections. Follow up to complete remarks from the
audits and inspections.
 Generate environmental or Safety incidents reports.
 Develop Performance Improvement or coaching actions plans for direct reports
 Support new product validations and transfers.
 Support the cleaning validation protocol development and execution
 Equipment IQ/OQ protocol execution
BAXTER HEALTH CARE CAROLINA P.R.
Manufacturing Supervisor Dec 1992- 1996
Duties:
 Supervise 25 hourly employee, this includes operator and technical support
 Lead and coordinate all the cleaning operations for clean rooms and mixing operation for I.V.
Solutions. Also these include the execution of filter integrity test, purified water sampling and
room microbiology sampling testing program.
 Document any deviation from the established process and implement the required CAPA’s.
 Keep all the areas in good pharmaceutical conditions as required by FDA, EPA and OSHA.
 Development and execution of cleaning and process validation protocols and reports in
agreement with Company Procedures, cGMP and FDA requirements.
 Lead the new product validation activities associated to Mixing and Cleaning activities.
 Revision, training, and documentation of the Pharmaceutical Technology Standard Operating
Procedures (Sop’s) and personnel as necessary for FDA Plant Certification.
 Ensure compliance of the approved Sop and cGMP's forthe different equipment, facilities and
systems.
 Recruit, train and complete the performance year-end review for direct reports

mobile: (787) 448-5169 or 787 648-2959
EDUCATION
UNIVERSITY OF PUERTO RICO – MAYAGUEZ Campus
1992 - Bachelor Degree in Chemical Engineering
SKILLS
Personal Skills:
Ability to work with high pressure, manages multiple tasks and heavy workloads, and consciously assigns
priorities to the day to day tasks with minimum supervision. Ability to tie all business processes as defined
within the organization while identifying gaps that may interrupt the natural flow. Has supervisory experience
with large and multidisciplinary groups. Fast learner. Fluent in both English and Spanish languages.
Continuously demonstrated throughout the years the capability to maintain good relationships at all levels
with peers, subordinates and indirect support staff which has been key in achieving results.
General Skills:
General knowledgeable in various business processes such as: Manufacturing, Packaging, Shipping,
Warehousing, Planning, Inventory Control, and Financial Analysis (Budgeting and Expense Control). Also
general knowledge in the application of Lean Six Sigma tools for the identification of continuous
improvement opportunities.
Knowledgeable in the use of EXCEL, PowerPoint, WORD, SAP, MES(WERUM), TRACKWISE and other
Site information management systems.
TRAININGS AND CERTIFICATIONS
2014 – SAP Super user, Train the Trainer
2011 – FETTE Basic use (mono layer and bi- layer tablets) and trouble shooting
2010 – Merck Sigma Yellow Belt (Lean Six Sigma Methodology), also participates as sponsor for green belt
Certifications
2007 – Elithabeth Hata basic operation and troubleshooting and in line in-process testing equipment
2000- Allen Bradley Basic PLC troubleshooting
1997 – Courtoy tablet press basic troubleshooting and calibration
1995 – Baxter Lean six sigma engineering program
1994 – Success Supervisor program training
PROJECT & ACHIEVEMENTS HIGHLIGHTS
ACHIEVEMENTS

mobile: (787) 448-5169 or 787 648-2959
Successfully lead the manufacturing activities for the product transfer to Arecibo plant such as: Vasotec,
Zocor and Mevacor. New Product validation in the Vioxx and Fosamax manufacturing process. Lead the
Proscar and Propecia elegance failures investigations and resolution. Finally support the Nexium drug
coating yield improvement process.
Assured that all the PE activities assigned to me on the SAP go-live were completed on time.
Also cero observation were received during the FDA audits to areas under my responsibility reacted to
execution, procedures or GMP compliance.
PROJECTS
Merck – Arecibo COMET (SAP implementation) Project 2008
 Blue print design for the Manufacturing areas
 Master Data development at the begging of the project
 Active participation on document revision and go-live activities
 Support the Master data improvement.
Merck – Las Piedras COMET (SAP implementation)Project 2014 to present
 Participated on the master data development and revision
 Perform the acceptant test
 Lead all the document revision activities (SOP’s and Batch records)
 Provide the requirement trainings for the personnel
 Lead the Manufacturing Support Hyper care activities
 Support the MES- WERUM implementation.

Pedro Perez

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