Jaime De Jesus Email and Phone Number
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Jaime De Jesus personal email
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Jaime De Jesus phone numbers
Summary: Jaime De Jesus has a 30 plus year career in the Pharmaceutical (sterile and non-sterile products, medical gasses), Medical Device (catheters, stents [Combo Devices], automated devices, ventilators and associated devices), and Food and Consumer industry (Foods, nutritional and other consumables including Class I Devices). He has started up both Medical Device and Pharmaceutical sterile product operations which resulted both in successful FDA approval process outcomes. He obtained his B.S. from the University of PR in 1977. He has 15 plus years experience in cGMP auditing (21 CFR 110, 210, 211; 600; 820; ISO 9001, 13485, EU, and Australian TGA. ) Languages (spoken and written): English, Spanish, and Portuguese (spoken only).Career Experiences: Have experience in Start up- new business/service/function (Medical Device Mfg. Plant, class 3 sterile device)Worked with situations to remediate compliance issues that led to Warning Letters in remediation teams. Experienced Trainer in Validation and cGMP Compliance.-Medical Device ISO 13485 trained auditor with Certificate- Technical writing, preparation of regulatory documents, led CM&C team that provided content for NDA submissions.- Good writing and communication skills; enabler for team building, leader of great working teams
Saol Therapeutics
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Retired, Available For Consulting And Partime AssignmentsQuality Multiple Services Jul 2022 - Present
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Director, Quality Assurance With Saol Therapeutics Lnc.Saol Therapeutics Lnc. May 2016 - PresentDirector, Quality Assurance with responsibility to manage the overall Quality System, company documentation systems, and product disposition process.
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Quality DirectorSaol Therapeutics 2016 - PresentRoswell, Ga, Us
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Associate Director QaMeda Mch May 2013 - Jun 2015Site QA Head, responsible for site compliance to 21 CFR 111 CGMPs and other applicable regulations.
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Quality Compliance ConsultantIndependent Contractor Dec 2012 - May 2013Provide services that promote compliance, conduct supplier audits, provide evaluation of quality subsystems such as CAPA, Change Management, etc. I can evaluate potential CMOs for high risk products such as aseptically filled sterile products. I have conducted trainings for cGMPs and QSR related sub-systems.
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Director, Corporate ComplianceIkaria Oct 2010 - Sep 2011Hampton, Nj, UsCorporate Quality, Safety and Environmental Compliance -
Qa DirectorRiver'S Edge Pharmaceuticals, Llc Dec 2009 - Sep 2010UsA DESI Drug, OTC and ANDA Generic Drug Distribution Company that uses contract manufacturing facilities to manufacture its products. At present, responsible for QA and compliance activities. -
ConsultantVivebio Llc 2009 - 2010Auditing CMOs, CSO, Suppliers and providing consulting services to Local Southeast companies.
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ConsultantMultiple Services Consulting Jan 2007 - Dec 2009Consultant, Quality Systems in the Medical Device, Pharmaceutical, and Consumer industries. Software and Process validation expert. Multi-lingual capability (english/spanish/ portuguese). Consulted with for Alimera Sciences, Alaven Pharmaceuticals, ViveBio LLC, and River's Edge Pharmaceuticals.
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Qa And Technical ConsultantAlimera Sciences 2007 - Feb 2009Alpharetta, Georgia, UsQuality Compliance Consultant- Quality Multiple Services, LLC -
Q&C Ww DirectorJohnson&Johnson 1996 - 2007New Brunswick, Nj, Us -
Qcww DirectorJ&J 1993 - 2007Liason with USA J&J Company Leaders to assure Quality and Compliance goals and initatitives were being supported and enforced throughout the J&J operating companies. Provide support and procure corporate resources as needed in support of company quality initiatives. Worked on recovery from FDA WLs, assessment of facilities, startups of new facilities, corporate training programs, and launch of new products in support of J&J companies .
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Qcww Account Director, Latin AmericaJ & J Corporate Jan 1993 - Dec 2006Corporate QA position which interacted with Latin American J&J Companies to support business initiatives and goals, and assure organizational regulatory compliance. Conducted audits to assure local compliance and adequate facilities, supported expansion of product exports to new markets, including review of new facility needs and supporting the efforts through assessments and resource needs identification. Assured compliance requirements for new markets were identified and implemented. Learned new language, Portuguese.
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Production ManagerSchering Plough, Las Piedras Jun 1985 - Dec 1992Rahway, New Jersey, UsHead of complex facility that utilized Wurster columns for fluid bed particle coating technology to prepare ingredients for sustained release products, blenders, and high speed compression machines. -
Production ManagerSchering Plough, Las Piedras 1985 - 1992Rahway, New Jersey, Us
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Technical SpecialistSmith Kline 1981 - 1985As Technical Specialist, supported the engineering team that developed the full design of a new sterile operations wing of an existing tablet operations building. Helped to identify "state of art" equipment such as Fedegari autoclaves, automated ampoule washing, strunck hot air sterilizer tunnels, and ampoule filling machines. Led the validation team, and successfully led the PAI FDA activity with no observations identified during FDA visit. Met the schedule to completion and approval timing expectations, assured completed documentation content by diligent review throughout the process.
Jaime De Jesus Skills
Jaime De Jesus Education Details
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Universidad De Puerto RicoGeneral -
University Of Puerto Rico, Río PiedrasGeneral
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Universidad De Puerto RicoBiology
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Universidad De Puerto RicoChemistry
Frequently Asked Questions about Jaime De Jesus
What company does Jaime De Jesus work for?
Jaime De Jesus works for Saol Therapeutics
What is Jaime De Jesus's role at the current company?
Jaime De Jesus's current role is Retired, with 30+ years of experience in Pharma, Medical Devices, and combo products, Quality Multiple Services can provide consulting and Partime support.
What is Jaime De Jesus's email address?
Jaime De Jesus's email address is gt****@****tel.net
What is Jaime De Jesus's direct phone number?
Jaime De Jesus's direct phone number is +177048*****
What schools did Jaime De Jesus attend?
Jaime De Jesus attended Universidad De Puerto Rico, University Of Puerto Rico, Río Piedras, Universidad De Puerto Rico, Universidad De Puerto Rico.
What skills is Jaime De Jesus known for?
Jaime De Jesus has skills like Validation, Capa, Pharmaceutical Industry, Gmp, Fda, Quality System, Quality Assurance, Quality Auditing, Medical Devices, Change Control, Quality Control, Pharmaceutics.
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