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Experienced Leader in Quality Assurance and Compliance with a demonstrated history of working in the pharmaceuticals industry including drug, device, and combination product. Skilled in Corrective and Preventive Action (CAPA), Complaint Investigations, Auditing, Quality Assurance, and Contract Manufacturing. Strong quality assurance professional with a Bachelor of Science (BS) Chemistry from The Ohio State University.
Pharmaceutical Consulting Solutions Llc
View- Website:
- pharmaconsultingsolutions.com
- Employees:
- 7
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General ManagerPharmaceutical Consulting Solutions LlcDublin, Oh, Us
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General ManagerPharmaceutical Consulting Solutions Llc Sep 2024 - PresentDublin, Ohio, UsCompliance consultant drug, device, and combination product. Design control, risk management, IQ/OQ/PQ, investigations, product complaints, audits, and validation. -
Head Of QualityAndelyn Biosciences Dec 2022 - Sep 2024Columbus, Ohio, UsCell Gene Therapy -
General ManagerPharmaceutical Consulting Solutions Llc Aug 2022 - Dec 2022Dublin, Ohio, UsCompliance consultant for drug, device and combinations product GMP. Design control, risk management, IQ/OQ/PQ, investigations, products complaints, audits, and methods validation.
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Specialist V, Compliance And ValidationHikma Pharmaceuticals Apr 2018 - Jul 2022London, London, GbImplementation of Design Control and Risk Management Plans. Review and approval of analytical, process, equipment, and computer validation. Host regulators authorities during inspections. Lead compliance teams to remediate new compliance requirements (nitrosamines, elemental impurities, etc..). -
Director 3Pm Quality And ComplianceHikma Pharmaceuticals Mar 2017 - Apr 2018London, London, GbQuality oversight for external and internal Contract Manufacturing. Manage QAA’s, change control, and compliance.
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Director, Quality AssuranceHikma Pharmaceuticals Mar 2016 - Mar 2017London, London, GbOversight of deviations, product complaints, release, and 3rd Party quality.
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Director, Quality AssuranceBoehringer Ingelheim Nov 2011 - Mar 2016Ingelheim Am Rhein, Rhineland-Palatinate, DeLead teams completing Product Record Review, Product Complaints, Investigations, CMO oversight, Auditing, Investigations, and CAPA -
Associate Director Process QualityBoehringer Ingelheim May 2011 - Nov 2011Ingelheim Am Rhein, Rhineland-Palatinate, DeLead process engineers (process validation and optimization) in solids manufacturing. Oversight of quality optimizers (review of in-process checks and batch records).
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Associate Director, Quality AssuranceBoehringer Ingelheim May 2008 - May 2011Ingelheim Am Rhein, Rhineland-Palatinate, DeDirect Investigations, Customer Complaint Handling, and CMO oversight.
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Manager, Stability LaboratoryBoehringer Ingelheim Apr 1999 - Apr 2008Ingelheim Am Rhein, Rhineland-Palatinate, DeOversight of Stability Program, Annual Stability Reports, APR's and Stability Laboratory
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Team Leader, Starting MaterialsSanofi Mar 1996 - Feb 1999Paris, France, FrSupervised team of 18 analytical chemists. Oversight to starting material release and Supplier Qualification. -
Section Head, Analytical DevelopmentRoxane Laboratories Inc Sep 1993 - Feb 1996Develop and validate analytical methods. Review and approve equipment qualifications, method validation reports, respond to deficiency letters. Participate in regulatory inspections presenting data and reports. -
Chemist Iii, Anaytical DevelopmentRoxane Laboratories Inc Sep 1991 - Aug 1993Develop and validate analytical methods. Author technical documents, procedures, training materials. Complete IQ/OQ/ PQ, instrument repair and training.
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Chemist I, Quality ControlRoxane Laboratories Inc Apr 1990 - Aug 1991Complete routine analytical testing for product release.
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ChemistThe Ohio State University Department Of Chemistry Jun 1988 - Mar 1990Organic synthesis using radio-labeled compounds, Protein purification, enzymatic assays, DNA sequencing, cloning and expression in E Coli
David Shell Skills
David Shell Education Details
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The Ohio State UniversityChemistry
Frequently Asked Questions about David Shell
What company does David Shell work for?
David Shell works for Pharmaceutical Consulting Solutions Llc
What is David Shell's role at the current company?
David Shell's current role is General Manager.
What is David Shell's email address?
David Shell's email address is ds****@****kma.com
What is David Shell's direct phone number?
David Shell's direct phone number is +161424*****
What schools did David Shell attend?
David Shell attended The Ohio State University.
What skills is David Shell known for?
David Shell has skills like Quality Assurance, Investigation, Capa, Complaint Investigations, Auditing, Contract Manufacturing, Regulatory Compliance, Analytical Method Validation, Process Validation, Validation.
Who are David Shell's colleagues?
David Shell's colleagues are Stephen Vaisey, Shailendra Nath.
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