Jose Rodriguez

Validation Specialist/QA Technician/Senior Manufacturing Technician (Pharmaceutical

& Biotechnology).

Salisbury, MD 21804

ac5uk0@r.postjobfree.com - 939-***-****

To obtain a position that will enable me to utilize my good visual acuity, observation skills and Process Validation experience in the Biotechnology Field and Pharmaceutical Industry making positive contribution to organization. Willing to relocate: Anywhere

Authorized to work in the US for any employer

WORK EXPERIENCE

Lead Operator

Jubilant Cadista - Salisbury, MD - November 2013 to Present I am Team Leader responsible to assist the management to reach the company's goal. I have been qualified in Pharmacy (weighing), screening, granulation, drying, milling and screening, blending, compacting, compression, coating.

Solid Dosage Manufacturing operator

Mc Neil - Puerto Rico - 2012 to 2013

Glatts Fluid bed dryers, milling, screening and blending operator. E.B.R./PAS-X Systems QA Technician

Mylan Pharmaceuticals - Caguas, PR - 2011 to 2012

Experience on prepare and execute Process Validation Protocols, support of site Validations Master Plans(VMP) by developing and executing assigned validations. Review and approve validations and completions reports for new and existing products, process and equipment. SAP,MES,NG LIMS . Responsible for the granulation drying LOD and final blend mesh analysis . Responsible for all analysis in the pre-compression process, including tablet weighing, thickness and logo verification, granulation density test, press speed qualification, friability test and desintegration test . Experience auditing batch records & manufacturing processes for EU, Canada, Australia, New Zealand, U.K., China, Japan and U.S. markets. Conduct preventive maintenance of measuring devices like tablets hardening tester, desintegration water bath, in order to meet G.M.P. requirements. Inspect and sample raw materials, intermediates, in process products for Q.A. lab testing. Experience working internal audits related to Q.A.. Experience in the major quality sytems: CAPA, Q.A. holds, materials rejection reports, deviation. Experience implementing new procedures and writing S.O.P’s..

Manufacturing Operator

Warner Chilcott - Fajardo de Bocas, Gto. - 2010 to 2011 Experience in the execution of Validation Protocols, performing Validation Master Plans, executing assigned Validations. Strong knowledge of quality assurance and engineering reviews of validation documentation. Experience in high potency products manufacturing. Kikusui Libra, Fette 3090i, Elizabeth Hatta, Manesty Mk4, Novapress compressing machine experience. Compressing machine operation training by Fette. Pre-Weight Technician

Procter & Gamble - Cayey, PR, US - 2009 to 2010

Responsible for the Incoming Materials used in the cosmetics products manufacture. Daily experience reviewing M.S.D.S., and managing hazardous materials. Experience in R.T.C.I.S. & S.A.P. Systems. Experience creating, reviewing, formatting, preparing and routing G.M.P. documents to Q.A. System Administrator in the Electronic Document Management System (EDM). Experience in the troubleshooting of process equipment. Process Validation experience(IQ,OQ,PQ). Q.A. Auditor

Marcoop Moldings - Fajardo de Bocas, Gto. - 2008 to 2009 Processing of incoming materials. Line clearance. Measuring, weighting and first piece approval. Preparation of batch records. Authorization of production starting. Process sampling of each machine (18), every two hours. Implementation of approval and rejection procedures. Labels preparation. Batch records auditing. Experience executing Validation protocols and Final Validation Reports . Support of site Validation Master Plans by developing and executing assigned Validations. Biologics Operator

Wyeth Ayerst Lederle Inc - Carolina, PR - 2005 to 2008 Media Fills Validation Training. Aseptic Techniques Qualification Program. Experience/Understanding of clean room (100) classification. Hands-in experience in Sterilization methods (gas chamber, Auto-Clave, dryer, Filtration). Parenteral Formulation, Filtration, Filling(R.A.B.S.) & Lyophilization process experience. Manufacturing Technician

Pfizer Pharmaceuticals - Caguas, PR - 2000 to 2005 Execution of Validation Protocols. Execution of Solid Dosage Manufacturing Operations (Weighting Granulating, Compressing, Film Coating and Capsule Filling). Experience Manufacturing Controlled Substances. Manesty rotapress Mk2, mk4, Rotapress, Novapress compressing machine experience. Compressing machines calipers & plates calibration training by Thomas Engineering. EDUCATION

B.A.

Universidad de Puerto Rico - Cayey, PR, US

1997

Banking High Honor Instituto de Banca - Cayey, PR, US 1994

B.S.E.E.

Universidad del Turabo - Caguas, PR

SKILLS

Team Leader with 22 years of Solid Dosage Manufacturing experience in Weihing, Screening, Granulation

( high shear granulator/Glatts fluid bed dryers), Drying ( ovens), Milling( Quadro Comill), Compaction

(Chilsonator Roll Compactor),Compression( Elizabeth Hatta, Manesty Rotapress MK2, MK4,Novapress, Fette 3090-I, Kikusui Libra, Courtoy R290-F). Experience on SAP,NG LIMS,HAN DEL,W&D/EB/ MESControlSystems, Core Java,FAT/SAT/IQ/OQ/PQ/PV/CVS-s. Participate in FDA inspection. Strong Knowledge of c'GMP as established in the Code of Federal Regulations 21CFR, Part11 210&211. Strong Knowledge of Quality Assurance and Engineering reviews of Validation Documentation. Experience in Pharmaceutical GMP aseptic environment, c'GMP training and knowledge. Experience on prepare and execute process protocols, Final Validation Reports. Training in Physical Chemical Principles of Pharmacy(Alexander Taylor,Florence D. Attwood 211 Medical) Training in potential changes during storage absorption and desorption of moisture and associated hardening and polimorphis conversion of excipients and adverse impact on manufacturing finishes products. Strong knowledge in tablets compression defects problem solving. Training in Reverse engineering on pre-compression force calculation and adjustment by Thomas Engineering. Training in Mechanical vs. Computed Dwell time calculation and adjustment by Fette.

(10+ years)

ADDITIONAL INFORMATION

My resume which is enclosed highlights my knowledge in Solid Dosage Manufacturing, Quality Assurance,and Validation Process

During my time at Mylan Inc I was able to implement new procedures and write S.O.P’s. I also experienced drafting initial S.O.P’s for the process and manufacturing equipment; validating revised S.O.P’s; and performing validation master plans; supporting manufacturing equipment; cleaning; and doing projects of process validations . I also conducted reviews of validation plans, study protocols and summary reports, developing documentation as required for projects; and consulting on validation and c’G.M.P. questions and issues. I have strong knowledge of c’G.M.P. as established in the C.F.R. 21 C.F.R. part 11, 210 &211. Also I have experience preparing validation protocols(FAT/SAT/IQ/OQ/PQ/PV/CSV-s), executing validation and creating completion reports. Experience in the major quality systems: Change Control, CAPA, Q.A.Holds, Material Rejection Reports, Deviation Investigation, Technical Complaints. Experience working on internal and external audits related to Quality Assurance. Experience implementing new procedures and writting S.O.P's. Hands-in experience in the Pharmaceutical/Biotechnology manufacturing process.