Digna I. Nieves Franco ***- ***-**** / 787-***-****

Jiménez Sanjurjo. St 2F-A3 adg744@r.postjobfree.com

Bairoa Park II, Caguas, PR 00727

SUMMARY QUALIFICATIONS:

Experience in the Pharmaceutical Industry in areas as Manufacturing Processes and Technical Operations, Product and Technology Transfer, Cleaning Validation, Equipment Qualification, and Quality.

SKILL:

●Knowledge of Common Computer Literal. ●Knowledge in GMP’s, FDA, EMEA and OSHA Regulations, ISO, MRP, SAP and EDM. ● Quality by Design Training. ●Manufacturing and Packaging Supervising Experiences. ●Support the execution of Manufacturing/Quality Systems such as Non-Conformances, CAPA`s, Change Controls, Complaints, Process and Cleaning validations ●Transfer product activities as: Validation Master Plan, Equipment Commissioning and Qualifications (Mfg, Facilities / Utilities ) Process Protocols, Final Reports, SOP`s, Training, etc.

EDUCATION:

Polytechnical University – PR Campus, Hato Rey, PR – A.D Mech.Eng – in process

University of Puerto Rico – Rio Piedras Campus, Rio Piedras, PR - 1997 - B.A. General Studies

PROFESSIONAL EXPERIENCE:

Compliance and Qualification Specialist -C&Q (Mentor technical Group- Temporary Contract):

Feb 2019 – Aug 2020 Janssen Gurabo, P.R

●Responsible for the Protocols and Qualifications documentation for facilities/ utilities,manufacturing and packaging equipments ●Execute IQ, OQ and PQ qualifications, addressing discrepancies, and developing technical and final validation reports.● Perform decommissioning activities● Perform non–conformance investigation, complaints, process quality reports, trend monitoring systems,updates procedures and work instructions ● Documenting Change Control to Equipment Changes.

Technical Operations Scientist (Val Tech Group- Temporary Contract):

Feb 2018- Oct 2018 Patheon (Thermo Fisher Scientific) Manati, P.R

●Work and execute manufacturing and packaging validations activities assigned (Process Execution, Process and Equipment Assessments, Discrepancies, Track Wise Events, Final Reports). ●Support the developing of the validation deliverables in according with the Technology Transfer and Validation. ●Coordinate with Manufacturing, Packaging, Engineering and Quality to define the process, packaging and cleaning validation interface. ● Execute IQ, OQ and PQ qualifications, addressing discrepancies, and developing technical and final validation reports

Technical Operations Scientist (Val Tech Group - Temporary Contract):

April 2016- Dec 2017 Janssen Gurabo, P.R

●Support the developing of the validation deliverables in according with the Technology Transfer and Validation. ●Coordinate with Manufacturing, Engineering, and Quality to define the process, packaging and cleaning validation interface. ●Work and execute the manufacturing and packaging validations activities assigned (Process Execution, Process and Equipment Assessments, Discrepancies, Track Wise Events, Final Reports).

Validation Scientist (Echo Consulting Group -Temporary Contract)

April 2015- August 2015 Amgen Juncos,P.R

●Provide technical support to cleaning activities and execution of Cleaning Validation testing ●Technical writing in Cleaning Validation protocols and reports executed ● Evaluate validation documents. ●Reviews and approves Cleaning Working Instructions Forms. ●Perform investigation of deviations/discrepancies ●Supports the periodic review of cleaning validation studies. ●Trains manufacturing/laboratory and QC/QA personnel on cleaning validation documentation.

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April 2014- Feb 2015 Neolpharma,Inc Caguas,P.R

Technical Services Scientist (PPS Consulting Group -Temporary Contract)

●Develop Technical Transfer Master Plan, Protocols, Cleaning Activities, Equipment Qualifications, (IQ, OQ, PQ) Procedures, Process Documentation, Assessments and Final Reports. ●Coordinate and enforce the execution of process and cleaning validation activities. ●Support the developing of the validation deliverables in according with the Technology Transfer and Validation Master Plan. ●Manage the respective validation plans by aligning, coordinating and executing the activities.

June 2013-March 2014 AstraZeneca (IPR) Canovanas, P.R

Technical Services Scientist (QRC Group - Temporary Contract)

● Provide technical support to cleaning activities associated with the manufacturing process. ●Technical writing in Cleaning Validation protocols and reports, execute, interpret, and evaluate validation documents. ●Reviews and approves Cleaning Working Instructions Forms. ●Perform investigation of deviations/discrepancies ●Supports the periodic review of cleaning validation studies.

Feb 2012 - Dec 2012 McNeil Pharmaceutical, LLC. Las Piedras, PR

Technical Services Scientist (Mentor Technical Group -Temporary Contract)

●Investigate and solve situation identified by Quality Control (Non-Compliances, Complaints, etc.) ●Write, Revise and Edit SOP’s (Manufacturing, Packaging and Utilities Areas) to assure compliance with GMP’s and FDA Regulations. ●Responsible to implement and execute Corrective Action-Preventive Action (CAPA’s), Action Item (AI) and Change Controls. ●Responsible for the implementation and fulfillment of the Consent Decree Working Plan in the Manufacturing Areas.

ADDITIONAL MANUFACTURING EXPERIENCES

Jan 2013- June 2013 Pepsi Co Cidra, P.R

Production Supervisor (Kelly`s Professional Services Temporary Contract)

●Responsible for the operational performance in the manufacturing area. ●Directs efforts towards the effective utilization of labor materials and equipment ensuring compliance with regulations and Company Policies. ●. ●Investigate and solve situation identified by Quality Control as Customers Complaints and Process and Equipment Deviations.

Aug 2006- Nov 2011 Mylan Caguas,P.R

Senior Manufacturing Supervisor

●Coordinate the manufacturing process and schedule performances in the Manufacturing Areas ●Appraisers Operators performance and makes recommendations for hiring, salary increases, promotions ●Pursue operational efficiency and Cost control with the effective utilization of labor, materials, and equipment ensuring compliance Company Policies. ●Support to Validation Group ●Assist Technical Services in special projects(Commissioning and Decommissioning manufacturing equipments).

2002-2006 Schering Plough LLC Las Piedras, PR

Manufacturing Supervisor

●Coordinate and supervise the manufacturing process and schedule performances in the Manufacturing Areas. ●Appraisers Operators performance and makes recommendations for hiring, salary increases, promotions. ●Pursue operational efficiency and Cost control with the effective utilization of labor, materials, and equipment ensuring compliance Company Policies. ●Support to Validation Group, assist in the development of special projects. ● Coordinate equipment qualifications (IQ, OQ, PQ) in the Manufacturing Area. ●Responsible for the implementation and fulfillment of the Consent Decree Working Plan in the Manufacturing Areas.

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2000-2002 Ivax Pharmaceutical Cidra P.R

Manufacturing Supervisor:

●Supervise and coordinate the manufacturing process and schedule performances in the Manufacturing Areas (Weighing, Granulation, Blending, Compressing, Coating and Encapsulation). ●Appraisers Operators and Documentations Clerks performance and makes recommendations for hiring, salary increases, promotions. ●Pursue operational efficiency and Cost control with the effective utilization of labor, materials, and equipment ensuring compliance Company Policies. ●Support to Validation Group, assist in the development of special projects.

1996-2000 Lilly del Caribe Carolina, PR

Assistant Supervisor:

●Supervision of manufacturing personnel and schedule in the Manufacturing Areas, (Weighing, Granulation, Blending, Compressing, Coating and Printing). ●Train operators in manufacturing procedures. ●Verify and approve all the documentation generated during the manufacturing process (Batch Records, Process forms, etc.)

1992-1996 Danbury Pharmaceutical Caribe Humacao, PR

Senior Operator:

●Company Start Up Team Member – Equipment Qualifications and Process Validation ●Operational experience in process equipment. ●Train and certify operators in manufacturing process. ●Verify the documentation generated in the manufacturing process (Batch Records, Process Forms and Cleaning Logs).

1988-1992 Smithkline Beecham Pharmaceutical Cidra, PR

Manufacturing Operator:

●Third Shift Facilitator: Coordinate the manufacturing process in the Granulation and Compression Areas.

REFERENCES:

Available Upon Request.

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