Senior Consultant
CurrentAudit of facilities and quality systems of finished products and API in US and India, remediation and Quality system gap analysis.
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Raghavan Krishnan is listed as Senior Consultant at Exemplar Compliance, a with 10 employees, based in Suffern, New York, United States. AeroLeads shows a matched LinkedIn profile for Raghavan Krishnan.
Raghavan Krishnan previously worked as Quality Assurance at Consumer Health Care and Consultant at Your Encore. Raghavan Krishnan holds Phd, University Department Of Chemical Technology from Technology.
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Quality Assurance Senior Manager CGMP Consent Decree (Verification and Compliance) -Consumer Healthcare Multi National –Quality System Elements.Interact with QSE Teams (Management Controls, Change Control, Quality Assurance, Materials and Components-Packaging Labeling, Printed Materials, Approved Suppliers, BSE/TSE) reviewing Standards, Gap analysis, SOPs (Standard Operating Procedures) creation and revisions, protocol review and implementation, Investigations and CAPASEnsure compliance with seven attributes (Process, Procedure, Documentation, Quality Assurance, Organization, Infrastructure and Metrics) Consent Decree -Quality Systems-Write SOPs and Skills Training Aids. Conduct training for technicians and professionals on CGMP requirements.Written over 60 SOPs and Training Aids to meet Consent Decree requirements.Worked in Pharmaceutical industry for 30 years. Plan and execute production schedules for Kilo Lab effectively utilizing facilities and maximizing personnel potential.Encourage utilization of new process technologies.Assist in the budget preparation of Kilo Lab operations.Work under cGMP guidelines, written the chemistry and manufacturing section for over 90 INDs. Familiar with scale up operations. Attended Leadership Development courses conducted by Columbia Graduate School of Business and also in house training on Leadership skills.Conducted Leadership training seminar for Global Software Solutions (New Jersey). Invited speaker at ChemSource in Mumbai for two consecutive years 2006, 2007 and MARM meeting in 2005. Past President of Park ToastMasters, Ramsey (New Jersey).Specialties: Areas of expertise: Grignard Reactions, Hydrogenations, Nitrations, Palladium Cross Coupling, Classical Resolutions and Dipolar Cycloadditions
Listed skills include Gmp, Pharmaceutical Industry, Chemistry, Sop, and 20 others.
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Audit of facilities and quality systems of finished products and API in US and India, remediation and Quality system gap analysis.
New Jersey
Gap Analysis, Remediation of Training and Change Controls, SOP
Quality Assurance Consent Decree Interact with QSE Teams (Management Controls, Change Control, , Materials and Components-Packaging Labeling, Printed Materials, Approved Suppliers, BSE/TSE) reviewing Standards, Gap analysis, SOPs (Standard Operating Procedures) creation and revisions, protocol review and implementation, Investigations and CAPASReview Training documentation, Quality System Standards, QA (Quality Assurance)
Engaged in advising High Net Worth Individuals in areas of investments with potential for growth.Also working with Institutional Investors in the Hedge Fund space.
Oversee the Kilo Lab operations and 16 direct reports in Pearl River.Responsible for the manufacture of Phase 0 and Phase 1 APIs (Active Pharmaceutical Ingredient) under cGMP conditions.
Pearl River Ny 10965
Plan and execute production schedules for Kilo Lab effectively utilizing the facilities and maximizing personnel potential. Encourage utilization of New Process Technnologies.Assist in the budget preparation of Kilo Lab OperationsOversee the Kilo Lab operations and 16 direct reports in Pearl River. Responsible for the manufacture of Phase 0 and Phase 1 APIs (Active Pharmaceutical Ingredient) under cGMP conditions. Familiar with all aspects of process development. Written protocols, INDs, NDAs (DMFs), SOPs. Conducted training on SOPs, STAs as related to consent decree. Completed leadership training courses conducted by Columbia Graduate School of Business.Detailed resume available on request.
Involved in the development of processes from bench to pilot plant. Familiar with tetracycline chemistry, platinum compounds and carbapenems.Successfully scaled up processes from bench to pilot plant. Responsible to implement cGMP practices and conduct training sessions for scientists in the department
Involved in the synthesis of Quinoline antibacterials, indazoles and quinolines and isoquinolines.
Other employees you can reach at exemplarcompliance.com. View company contacts for 10 employees →
David Wallace
Colleague at Exemplar ComplianceSan Francisco Bay Area, United States
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Gary Knight
Colleague at Exemplar ComplianceNew York, United States
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Gwendolyn Paige
Colleague at Exemplar ComplianceKyle, Texas, United States
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Amber Birmingham Johnston
Colleague at Exemplar ComplianceStorrs, Connecticut, United States
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Joy Langley
Colleague at Exemplar ComplianceMapleton, Utah, United States
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Business Development
Colleague at Exemplar ComplianceAustin, Texas, United States
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Quick answers generated from the profile data available on this page.
Raghavan Krishnan works for Exemplar Compliance.
Raghavan Krishnan is listed as Senior Consultant at Exemplar Compliance.
Raghavan Krishnan is based in Suffern, New York, United States while working with Exemplar Compliance.
Raghavan Krishnan has worked for Exemplar Compliance, Consumer Health Care, Your Encore, Blue Spruce Global Advisors, Llc, and Pfizer Pharmaceuticals.
Raghavan Krishnan's colleagues at Exemplar Compliance include David Wallace, Gary Knight, Gwendolyn Paige, Amber Birmingham Johnston, and Joy Langley.
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Raghavan Krishnan holds Phd, University Department Of Chemical Technology from Technology.
Raghavan Krishnan is listed with skills including Gmp, Pharmaceutical Industry, Chemistry, Sop, Validation, Quality Assurance, Consent Decree, and Technology Transfer.
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