John Osler Email and Phone Number
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A quality-driven Pharmaceutical professional with expertise in cGMP Laboratory Operations, specializing in QA/QC Compliance, Quality System improvement, Data Integrity controls, and Inspection-readiness.Extensive technical experience in Analytical Development and regulatory CMC review. Skilled Team Leader with strong Project Management, remediation, and process optimization experience, including successful cross-functional, multi-site, & international initiatives.Successful and diverse career spans 25+ years from technical to senior management roles, with positions progressing from Research Scientist to Director to Independent Technical Consultant.Currently providing consulting services to Pharmaceutical and Biotech clients, as Founder & Senior Principal Consultant at The QualiCeutics Group, LLC. (www.qualiceutics.com)Core Competencieso GMP Lab Compliance & Remediationo Data Integrity Assessment & Controlso Inspection-readiness (Mock PAIs, Audits)o 21CFR Part 11 implementationo Quality System Efficiencieso Computer System Validationo Lab Management o Technical Project Managemento GMP Technical Trainingo Technical Writing o Lab System & Automation Improvementso CMC (Quality) Technical Document Preparation for Regulatory Submission Specialties: Pharmaceutical Consulting & Resources, Analytical Development & Quality Control, Lab cGMP Compliance & Remediation, Quality System Implementation, Project Management, CMC (Chemistry, Manufacturing & Controls) and eCTD preparation, Enterprise-wide systems and validation; LIMS, EDMS, Chromatography Data Systems, etc.
The Qualiceutics Group
View- Website:
- qualiceutics.com
- Employees:
- 1
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President And Senior Principal ConsultantThe Qualiceutics GroupFairport, Ny, Us
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President & Senior Principal ConsultantThe Qualiceutics Group Jul 2012 - PresentRochester, New York AreaServing Pharmaceutical and Biotech clients with consulting and contract expertise in Quality Control (QC) and Laboratory Quality Systems, including:• Lab Audits & Compliance • 21 CFR Part 11 & Data Integrity Assessment • Instrument Qualification • Lab Systems & Computer System Validation• LIMS Implementation • Technical Project Management• Technical Writing • Method Validation & Transfer Review• GMP Technical Training • CMC… Show more Serving Pharmaceutical and Biotech clients with consulting and contract expertise in Quality Control (QC) and Laboratory Quality Systems, including:• Lab Audits & Compliance • 21 CFR Part 11 & Data Integrity Assessment • Instrument Qualification • Lab Systems & Computer System Validation• LIMS Implementation • Technical Project Management• Technical Writing • Method Validation & Transfer Review• GMP Technical Training • CMC (Quality) Regulatory Submission Preparation & Review Show less
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Director Of Program Management, Life SciencesRaland Technologies, Llc May 2011 - Jun 2012Rochester, New York Area -
Associate Director - Cmc Knowledge ManagementUcb Pharma Jul 2008 - Jun 2010Braine-L'Alleud, Belgium -
Sr. Group Leader - Analytical DevelopmentUcb Pharmaceuticals Inc May 2004 - Jun 2008Rochester, New York Area
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Manager/Senior Chemist – Analytical DevelopmentCelltech Pharmaceuticals Nov 1999 - May 2004Rochester, New York Area
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Supervisor/Research Scientist – Analytical DevelopmentWyeth Pharmaceuticals Mar 1989 - Oct 1999Pearl River, New YorkPearl River, NY site: 1996-1999Rouses Point, NY site: 1989-1996
John Osler Skills
John Osler Education Details
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Chemistry -
Chemical Technology
Frequently Asked Questions about John Osler
What company does John Osler work for?
John Osler works for The Qualiceutics Group
What is John Osler's role at the current company?
John Osler's current role is President and Senior Principal Consultant.
What is John Osler's email address?
John Osler's email address is jo****@****and.com
What is John Osler's direct phone number?
John Osler's direct phone number is +158594*****
What schools did John Osler attend?
John Osler attended Rochester Institute Of Technology, Alfred State College - Suny College Of Technology.
What are some of John Osler's interests?
John Osler has interest in Small Business, Travel, History.
What skills is John Osler known for?
John Osler has skills like Gmp, Validation, Lims, 21 Cfr Part 11, Quality Control, Technology Transfer, Analytical Chemistry, Fda, Quality System, Pharmaceutical Industry, Laboratory, Regulatory Submissions.
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