Quality Project

CLAUDIA A. STANCIU

**** ******* ***** **. *****: 252-***-**** (cell)

Wilson NC, 27896 e-mail address: **************@*****.***

Quality Assurance Regulatory Affairs (QARA) Professional

Dynamic QARA professional with 17+ years background experience in the pharmaceutical, biopharmaceutical, vaccine, OTC, homeopathy and device industries focusing on Quality Management Systems. Proven skills are: comprehensive understanding of FDA, MHRA, Japanese and Canadian Regulatory Requirements (GMP, QSR, GLP, GXP, NDA, IND, ISO, ICH); excellent planning, organizational and time management skills; excellent problem solving, risk analysis and negotiation skills; ability to work independently by managing multiple projects; ability to establish and maintain effective working relationships with coworkers, managers and clients.

AREAS of EXPERTISE

Regulated Industry Compliance Consultant

oVendor, Supplier, Contractor, Mock FDA, Consultant Audits

o‘Due-Diligence’, ‘For-Cause’ & 483 Site Remediation

oGMP Audits (21 CFR Part 210/211, ISO, ICH Q7A) CAPA Management

oQuality Systems Design Programs and Methodology

oKey player in various Project Management activities utilizing MS Project/Visio tools

Validation Services

oLaboratory Equipment Validation (HPLC, GC, AA, FTIR, UV Vis, Agilent/HPChemStation, Fume Hoods, Bio-Cabinets, HVAC, Class 100 – 100K

oComputer System Validation and Protocol Execution (BMS, EDC, MRP, LIMS, SCADA, QDMS, PLC Custom and COTS applications)

oEngineering Systems Development (parenterals robotics packaging lines, bottles and blisters configurations)

21 CFR Part 11 Site(s) Remediation Initiative Project Management

Technical Quality support: Packaging Engineering, Manufacturing and R&D

On-Site Training and Development:

o21 CFR Parts 210/211 Drug GMPs

o21 CFR Parts 11 – Electronic Records; Electronic Signatures

PROFESSIONAL EXPERIENCE

9/14 to 01/15: Edwards Lifesciences –Draper, UT

Title: Quality Compliance Consultant

Supported the implementation, and continuous improvement of a new established CAPA system

Key responsibilities include writing manufacturing investigations, assigning corrective actions for the Cardiovascular Central Systems (CCS) unit

Assisted with developing and implementation measures to monitor the effectiveness of quality systems and drive remediation for improvement

6/13 to 12/14: Eisai Inc. –Raleigh, NC

Title: Sr. Quality Auditor

Planed, prepared and performed audits according to the schedule for the commercial and clinical products at RTP, Baltimore and Global Audits.

Performed internal audits and supported Regulatory Agency audits at RTP site.

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.

6/10 to 1/13: TruePharma Solutions LLC (short term consulting projects)

Title: Quality Consultant – Quality API Manufacturing – Roche Hoffman, Florence, SC.

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.

Title: Quality Consultant – Validation Engineering – Nova Nordisk, Clayton, NC.

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.

Title: Director Assistant Consultant – Supplier Quality - Apotex Inc., Toronto Canada.

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.

Title: Compliance Consultant Project Manager - Validation Engineering, Hospira Rocky Mount NC.

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.)

5/09 to 6/10: Becton and Dickinson (BD), Wilson, NC

Title: Manager Quality Auditor

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.

6/05 to 5/09: Adecco (consulting services provided):

Title: Quality Assurance Consultant - Novartis, Holy Springs, NC

oSupported Quality Operations and QC Management with method transfers of new products to the new Biopharmaceutical Novartis facility

oReviewed/Approved Validation Protocols (IQ, OQ, PQ, Summary Reports)

oAssisted in the design of the QMS (Change Control, CAPA)

oParticipated in second, third party audits and internal audits

Title: Quality Engineer - Banner Pharmacaps, High Point, NC

oPerformed designated Quality Representative functions in R&D and commercial areas (laboratory, validation, vendor audits, and internal regulatory inspections)

oResponsible for Clinical R&D and Regulatory preparation of CMC-related submissions to FDA and other regulatory authorities worldwide

oAssisted in the development and execution of CMC regulatory strategies and regulatory submissions for (NADA and ANADA) of generic pharmaceutical products.

oPrepared CMC regulatory documents from technical departments in R&D/Operations/Quality for submission to FDA and (where applicable) international regulatory authorities using e-CTD submission gateway.

oMaintained awareness of and expertise in ICH, FDA and EU guidelines related to CMC regulatory topics

oResponsible for identifying negative trends in quality compliance resolving deficiencies through CAPA analysis

oConducted Mock FDA Audits and Pre-Audit Preparations

Title: Validation Engineer Consultant - BIOMERIEUX INC, Durham, NC

oSupervised 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

oIntegrated input from the Functions represented by the Project Team to reach a joint solution which maximized business value and met technical objectives

oManaged Project risks and mitigated plans within the Project Leader

oMapped validation activities to enhance the environmental program of the site, ensuring corrective actions were implemented

Title: Quality Assurance Manager- BOIRON Pharma, Newtown Square, PA

oManaged the new Facility Construction project and mitigated risk assessments interacting at all organizational functional levels reporting directly to company’s VP

oManaged and carried out the Scope of Works, Definitions, Estimates, Requests for Funding for the new construction contracts by taking ownership of budget, schedule and resource control of projects.

oParticipated 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

oParticipated in FDA regulatory inspections, investigations, and inquiries regarding the control and assessment of product quality and manufacturing consistency

oParticipated in FDA regulatory inspections, second and third party international audits

5/97 to 9/04 - MERCK PHARMACEUTICALS, Wilson, NC.

Title: Quality Assurance Supervisor

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

Title: Senior Analytical Chemist

Responsible for Laboratory Equipment Validation:

oHVAC, Fume Hoods, Bio-Cabinets, Glove boxes

oHPLC, GC, AA, Spectrophotometers

oSoftware – LIMS, Pinnacle Millennium, Agilent/HPChemStation

oDetectors, FTIR, UV Vis, Diode Array, Gas Flame, MassSpec

oConducted Asset Inventories and Gap Analysis

Developed new techniques for the analysis of drug products and chemicals

Worked 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

EDUCATION:

Master Degree (QARA Certification), 2007; Temple University, Fort Washington, PA

Bachelor of Science in Chemistry, 1995; Temple University, Philadelphia, PA

Bachelor of Arts in Biology, 1994; Temple University, Philadelphia, PA

RELATED COURSE OF WORK:

Regulatory Affair Certification (RAC)

Certified Quality Auditor (CQA)

Certified Quality Engineer (CQE)

Six Sigma-Green Belt Certified

Computer Skills including: Microsoft Office; Word; Excel; Power Point; MS Project; QDMS/Documentum/r-Docs; SAP; Trackwise, LIMS, WATS, ISOTrain; Atlas, QDMS, AutoCAD; Empower3, SAP.

Various training seminars: GMP, ISO, HPLC, GLP, FDA and the Industry, FDA Initiative “Pharmaceutical GMPs for the 21st Century: A Risk-Based Approach”; Project Management; Manufacture of Sterile Medicine; Compliance Pharmaceutical Auditing

LANGUAGES:

Fluent in French, Romanian and proficient in Italian.

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