Manager Plant

RESUME

Sandra E. Rodríguez Castells

**** ******* ***** **. **** Worth, TX 76179

Telephones 787-***-****, 590-2375

JOB OBJECTIVE

Identify a challenging position in a highly recognized and organized company that will allow me to provide my professional services and yet and still be able to further expand my knowledge in the Pharmaceutical Sciences field.

BUSINESS EXPERIENCE

2012-2019 Technical Services Investigations Manager/Pharmacist

Mylan LLC

Responsible for the supervision, coaching and development of the Technical Services Investigations Team. Provide guidance in the resolution of scientific/technical issues within the manufacturing/packaging area. Interpret analytical and historical data to support manufacturing, product development (R&D), validation process, and commercial complaints investigations. Use statistical analysis tools, stability data, validation reports, APRs as resources to support the root cause analysis. Work with QA Investigations, QA Compliance, QA Operations, Engineering, and Manufacturing areas providing technical leadership towards the identification of the root causes for investigations due to process failures during validation transfers, commercial products (including product withdrawals/recalls assessments), and stability failures. Responsible for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance. Perform, revise and analyze complaints’ investigations to assure that accurate root causes and corrective/preventive actions are identified. Responsible for submitting the global escalation investigation documentation when required. Analysis of data and based on the trends recommends actions for process, equipment and system improvement. Act as scientific/technical expert and leads the development of scientific strategies with Technical Services process improvement area. Promote a continuous improvement culture within the above-mentioned processes. Accountable for the on-time closure of events, investigations, trending assessments, and CAPAs. As the Pharmacist in Charge and TS Investigations Manager of the plant, I was responsible to receive and provide response to the FDA, Puerto Rico Health Department, and Japan audits in conjunction with the QA Compliance area.

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2008-2012 Staff Pharmacist

Concilio de Salud Integral de Loíza / Pharmacy

Responsible of the preparation, verification and dispensing of drugs by interpreting prescriptions in this primary care center. Evaluation of patient’s profile by identifying drug-drug interactions, drug-food interactions, allergies, therapy duplicity and others. Maintain the pharmacy inventory using RX30 System. Work with Department of Health programs like ADAP (HIV Program) and Family Planning. Develop reports related to the administration of the pharmacy.

2004-2008 Pharmacist (On a Contract Part Time Basis)

University District Hospital (Centro Médico de Puerto Rico)

Provide support to the physicians and nurses in all aspects related to the drug therapy of the patients. Responsible of the preparation, verification and dispensing of drugs by interpreting medical orders. Evaluation of patient’s profile by identifying drug-drug interactions, drug-food interactions, allergies, therapy duplicity and others.

2001-2002 Manufacturing Manager

Biovail Laboratories

Responsible for the coordination of all activities related with the Manufacturing Department of Extended Release products in Biovail Laboratories. Responsible for the scheduling, budgeting, training and coordination of the necessary production and manning requirements to accomplish plant’s production objectives complying with regulatory and quality standards. Develop departmental objectives aligned to company corporate goals. Coordinate materials requirements with Logistics department in order to assure availability of proper raw materials to guarantee production output. Responsible also, for the coordination of the validation processes of all the manufacturing equipment at plant site. As the lead Pharmacist in the plant, I was responsible to receive and provide response to the Health Department and FDA audits.

1999–2001 Manufacturing Supervisor / Solid Dosage Forms

Biovail Laboratories

Responsible for the coordination of all the activities related with the manufacturing of extended release beads products including weighing, granulation, extrusion, spheronization, coating and drying processes. These activities can be summarized as follows:

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Coordinate weekly production schedule in accordance with marketing requirements and considering plant inventories and equipment resources. Coordinate materials requirements with Logistics department in order to assure availability of proper raw materials to guarantee production output on a weekly basis.

Develop troubleshooting techniques in coordination with Engineering and Quality Assurance departments to anticipate any major issue that could impair manufacturing

objectives in the production areas. Perform any investigational report required due to incidents associated with the manufacturing process.

Generate and revise Standard Operating and Manufacturing Procedures when deemed necessary. Responsible also for the training of colleagues when documents are either new or subject to revision.

1992 -- 1999 Manufacturing Supervisor / Parenteral Process - Biotechnology Pharmaceutical

AMGEN Puerto Rico

Responsible for the coordination of all the activities related with the formulation and filling processes in the manufacturing area of parenteral products. Responsible also for the scheduling and coordination of the necessary manning requirements to accomplish plant’s production objectives. Coordinate materials requirements with Logistics department in order to assure availability of proper raw materials and packaging components to guarantee production output on a weekly basis. Develop troubleshooting techniques in coordination with Technical Services, Engineering and Quality Assurance departments to anticipate any major issue that could impair manufacturing objectives in the production areas. Responsible also, for the execution of re-validation processes for the manufacturing equipment at the plant site. Participate in FDA, MCA and any other regulatory agency audit. Responsible for the development of all Standard Operating Procedures (SOP’s) of the Filling area during the start up process of the Manufacturing area at Amgen.

EDUCATIONAL BACKGROUND

2018 Texas Board of Pharmacist License – 63134

1987 - 1990 University of Puerto Rico, Medical Sciences Campus

Bachelor Degree in Pharmaceutical Sciences

Honor Index: 3.49

Cum Laude

Puerto Rico Pharmacist License: 4481

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1985 - 1997 University of Puerto Rico, Rio Piedras Campus

Pre-Pharmacy

Academic Index: 3.41

100 Honor Group

RECOGNITIONS AND AWARDS

Member of National Honor Society of the CIEM High School Student Chapter,

Member of the 100 Honor Group, Member of the Rho Chi Pharmacy Honor Society,

Cum Laude Honor at University of Puerto Rico Medical Sciences Campus

OTHERS

Computer Knowledge: Working experience with the following software: Excel, Power Point, Word, Trackwise and others.

Seminars: CGMPs Certification, Coaching Training, Train the Trainers Seminar, Management Operations Course, Granulation, Tableting and Encapsulation Course, BSL (CPR)

Bilingual: English and Spanish

REFERENCES

Available upon request.

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