claudia stanciu
Sr. Quality Auditor at Eisai Medical Research- Claim this Profile
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English Native or bilingual proficiency
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Romanian Native or bilingual proficiency
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French Professional working proficiency
Topline Score
Bio
Credentials
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CQA
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CQE
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RAC
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Experience
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Eisai Medical Research
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Sr. Quality Auditor
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Apr 2013 - Present
STERILE DRUG MANUFACTUIRNG FACILITY• Planed, prepared and performed audits according to the schedule for the commercial and clinical products at RTP and Baltimore.• Performed internal audits and supported Regulatory Agency audits at RTP.• Performed routine follow up of performed audits in conjunctions with site management• Interfaced with other global audit functions to support Eisai vendors on a global basis.• Responsible for ensuring that all vendors meet the expected level of GMP quality and compliance and provides input on the acceptability of current and new vendors. • Demonstrated effective teamwork by developing strong relationships with internal/external customers, peers and management and through effective oral and written communication. • Designed Eisai’s Global Quality Manual and Management Review SOP.
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Roche
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Switzerland
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Biotechnology Research
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700 & Above Employee
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Quality Assurance Consultant (short term project-TruePharma Solutions LLC)
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Jul 2012 - Apr 2013
API MANUFACTURING FACILITY• Reviewed/Approved Design, IOQ Protocols, Commissioning Protocols, and Summary Reports.• Analyzed, reviewed, and approved protocol test results.• Provided technical assessments for the Validation Department to support the TrackWise Change Control process and standard operating procedure changes.• Lead qualification efforts on project teams by representing the Site Quality department and coordinating activities of Operations, Quality, and Utilities Projects.• Lead the efforts to evaluate gaps in the process and compliance through the CAPA system for the roll out of new/revised Quality Policies and Standards.• Supported the internal audits effort through remediating efforts pertained to quality validation.
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Novo Nordisk
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Denmark
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Consultant (short term project-TruePharma solutions LLC) )
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Jan 2012 - Jul 2012
STERILE DRUG MANUFACTURING• Designed validation studies, authored and approved protocols, and ensured alignment with corporate standards and guidance for validation for an automated inspection machine to be transferred from France to the US, Clayton facility.• Developed technical and manufacturing documents necessary for engineering studies, process demonstration, and validation.• Compiled and maintained regular status reports and specific timelines using Microsoft Project to create, update, and manage the project plan.• Lead vendor and internal quality audits associated with the new product project.
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Apotex Inc.
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Canada
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Pharmaceutical Manufacturing
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700 & Above Employee
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Assistant Director, Supplier Quality Consultant (short term project - TruePharma Solutions, LLC)
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May 2011 - Dec 2011
GENERIC DRUG PRODUCT and STERILE MANUFACTURING• Responsible for managing a group of 12 team members in the development of a Supplier Management Program. • Interacted with Global Director of Quality to ensure project deliverables were met in accordance with timelines and departmental budgets.• Analyzed supplier capabilities, developed and maintained supplier quality metrics.• Developed programs and processes to validate and sustain the validation state through change management, continuing validation studies and audit participation.• Planned and conducted scientific investigations to assist developing initial manufacturing parameters or to determine root cause of failures and develop corrective actions.
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Hospira
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Compliance Consultant - Validation Engineering
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Aug 2010 - Jul 2011
STERILE DRUG MANUFACTURER• Participated in ‘Due-Diligence’ and 483 Site Remediation strategies; developed Validation Master Plans and Corporate Validation Compliance Transition Plans• Responsible for all regulatory matters to ensure compliance to regulatory requirements were achieved.• Liaise with the corporate US Regulatory personnel, managed product regulatory registration activities for all new and transferred products per project timelines.• Provided technical data to other sites in support of country specific product registrations and regulatory requirements in regard to validation studies in support of process demonstration (shipping, transportation, container closure, filter validation, etc.)
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Sandoz
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Compliance Consultant - Validation Engineeting (short term project-TruePharma Solutions LLC)
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May 2010 - Aug 2010
DRUG PRODUCT MANUFACTURER• Project Leader responsible for the development and successful qualification of the Siemens Apogee Building Management System (BMS)• Developed and approved URS, FRS, DS, IQ, OQ, PQ validation protocols for Maintenance, Utilities, Material Management, PLC, Compliance and Engineering systems DRUG PRODUCT MANUFACTURER• Project Leader responsible for the development and successful qualification of the Siemens Apogee Building Management System (BMS)• Developed and approved URS, FRS, DS, IQ, OQ, PQ validation protocols for Maintenance, Utilities, Material Management, PLC, Compliance and Engineering systems
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BD
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United States
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Architecture and Planning
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Lead Quality Auditor
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Jan 2009 - May 2010
STERILE DRUG MANUFATURER• Assisted with approval and implementation of Process, Facility & Equipment, Computer Systems (EDC, MRP, LIMS, SCADA, QDMS, PLC Custom and COTS applications) for a new BD construction facility• Designed the supplier audit program and associated Procedures ensuring compliance with the European and US regulatory standards • Lead CAPA activities with suppliers to ensure effective responses to audit findings for adequacy and timeliness• Participated in the development and delivery of cGMP training programs including annual cGMP training, new-hire cGMP training, contractor cGMP training, auditor training, and regulatory inspection preparedness training• Orchestrated continuous improvement activities with suppliers (Six-Sigma; Lean)• Managed the implementation of packaging engineering projects to sustain technical competence, project schedule and project budget control.
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Consultant
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Aug 2008 - Jan 2010
VACCINE MANUFACTURER (BIOTECH) Supported Quality Operations and QC Management with method transfers of new products to the new Biopharmaceutical Novartis facility Reviewed/Approved Validation Protocols (IQ, OQ, PQ, Summary Reports) Assisted in the design of the QMS (Change Control, CAPA) Participated in second, third party audits and internal audits VACCINE MANUFACTURER (BIOTECH) Supported Quality Operations and QC Management with method transfers of new products to the new Biopharmaceutical Novartis facility Reviewed/Approved Validation Protocols (IQ, OQ, PQ, Summary Reports) Assisted in the design of the QMS (Change Control, CAPA) Participated in second, third party audits and internal audits
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bioMerieux
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France
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Biotechnology Research
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700 & Above Employee
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Validation Engineer Consultant (Adecco)
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Jan 2007 - Feb 2009
MEDICAL DEVICE - STERILE MANUFACTURERSupervised a cross-Functional team to deliver new products and services within defined business requirements of cost, quality and time, in accordance with applicable regulations and company policies and procedures Integrated input from the Functions represented by the Project Team to reach a joint solution which maximized business value and met technical objectives Managed Project risks and mitigated plans within the Project Leader Mapped validation activities to enhance the environmental program of the site, ensuring corrective actions were implemented
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Laboratoire Boiron
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Canada
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Quality Assurance Manager
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Mar 2006 - Feb 2008
HOMOEPATHIC MANUFACTURER Managed the project development and expansion of a new facility located in Burbank, CA Mitigated gaps based on risk assessments, interacting with peers at all organizational levels and reporting directly to the VP of Quality Managed and carried out the Scope of Works, Definitions, Estimates, Requests for Funding of the new construction contracts by taking ownership of budget, schedule and resource control of projects. Participated in the design and qualification of the QC Laboratory ensuring all equipment and systems were purchased, installed and qualified according to company’s policies and regulations Participated in FDA regulatory inspections, investigations, and inquiries regarding the control and assessment of product quality and manufacturing consistency Participated in FDA regulatory inspections, second and third party international audits
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Merck
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Supervisor
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Jun 2002 - Mar 2006
DRUG PRODUCTand PACKAGING MANUFACTURER Managed second shift packaging operation responsible for material control, finished product release, batch record review, atypical investigations, process change control, validation, contract packaging, complaint investigations Conducted weekly Laboratory and Manufacturing Audits Completed Annual Product Reviews Participated in FDA regulatory inspections and product recall action as part of the regulatory submission process
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Senior Analytical Chemist
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Mar 1998 - Jun 2002
DRUG PRODUCT and BIOTECH MANUFACTURERResponsible for utilizing and validating Laboratory Equipment: HVAC, Fume Hoods, Bio-Cabinets, Glove boxes HPLC, GC, AA, Spectrophotometers Software – LIMS, Pinnacle Millennium, Agilent/HPChemStation Detectors, FTIR, UV Vis, Diode Array, Gas Flame, MassSpec Conducted Asset Inventories and Gap AnalysisDeveloped new techniques for the analysis of drug products and chemicalsWorked for the stability, microbiology, analytical and validation group being aware of, and keeping up to date with, health and safety issues in all aspects of the laboratory work
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Education
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2012 - 2016
University of North Carolina at Chapel Hill
PhD Pharmaceutical Sciences, Pharmaceutical Sciences -
2000 - 2003
Temple University
Quality Assurance Regulaatory Affairs Program, Pharmaceutical Sciences -
1990 - 1995
Temple University
Bachlor of Science, Engineering Chemistry
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