pedro perez

PEDRO PEREZ LOPEZ Hc-01 Box 11528, Carolina, PR 00987 mobile: (787) 448-5169 or 787 648-2959

email: [email protected]

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 RicoProcess 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.

mailto:[email protected]



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.

MERCK SHARP & DOHME INTL GMBH (PR BRANCH) LLC, Las Piedras, Puerto RicoAssociated 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.

MERCK SHARP & DOHME INTL GMBH (PR BRANCH) LLC, Arecibo, Puerto RicoManufacturing 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.

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 meet the schedule and production goals, raise any potential issue that can affect the areas performance.





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.


Coordinate manufacturing and packaging schedules for the areas.

Participate in Emergency Response responsibilities

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. Participate in daily TIERs meetings which include discuss manufacturing

quality events, metrics, supply, safety, and task assigned. Development improvement plan on areas that need improvement




Support the development and execution of cleaning and process validation protocols, automated systems performance monitoring and reports in agreement with Company Procedures, cGMP and FDA requirements.

Support strategies and resources to meet the schedule and production goals, raise any potential issue that can affect the area performance


Support the Maintenance Department in the area equipment and instrumentation Preventive 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.

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- 1996Duties:

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 for the different equipment, facilities and systems.

Recruit, train and complete the performance year-end review for direct reports

EDUCATION




UNIVERSITY OF PUERTO RICO – MAYAGUEZ Campus1992 - 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 shooting2010 – Merck Sigma Yellow Belt (Lean Six Sigma Methodology), also participates as sponsor for green belt Certifications2007 – Elithabeth Hata basic operation and troubleshooting and in line in-process testing equipment2000- Allen Bradley Basic PLC troubleshooting1997 – Courtoy tablet press basic troubleshooting and calibration1995 – Baxter Lean six sigma engineering program1994 – Success Supervisor program training




PROJECT & ACHIEVEMENTS HIGHLIGHTS

ACHIEVEMENTS 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.


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