Quality Assurance Project Manager
Resume:
CLAUDIA A. STANCIU
Phone: 252-***-**** (home); 252-***-**** (cell)
Wilson NC, 27896
e-mail address: **************@*****.***
Quality Assurance Regulatory Affairs (QARA) Professional
Dynamic QARA professional with 14+ 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 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
o Vendor, Supplier, Contractor, Mock FDA, Consultant Audits
o ‘Due-Diligence’, ‘For-Cause’ & 483 Site Remediation
o GMP Audits (21 CFR Part 210/211, ISO, ICH Q7A) CAPA Management
o Quality Systems Design Programs and Methodology
• Validation Services
o Laboratory Equipment Validation (HPLC, GC, AA, FTIR, UV Vis, Agilent/HPChemStation, Fume Hoods, Bio-Cabinets, HVAC, Class 100 – 100K
o Computer System Validation and Protocol Execution (BMS, EDC, MRP, LIMS, SCADA, QDMS, PLC Custom and COTS applications)
o Engineering 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:
o 21 CFR Parts 210/211 Drug GMPs
o 21 CFR Parts 11 – Electronic Records; Electronic Signatures
PROFESSIONAL EXPERIENCE
6/10 to present: TruePharma Solutions LLC (short term consulting projects)
Title: Supplier Quality Consultant – Director Assistance - Apotex Inc., Toronto Canada.
• Responsible for developing and strengthening Supplier Management Programs.
• Interact routinely with Purchasing, Engineering and Suppliers to improve quality of components (bottles, caps, pumps, labels, etc
• Analyze supplier capabilities. Develop and maintain supplier quality metrics.
• Perform supplier Quality Systems audits and provide support for supplier Quality Systems improvements and manage suppliers’ corrective actions
• Maintain and improve existing quality systems processes.
• Liase with Manufacturing, Quality engineers in the Business Units, in assessing and addressing material quality issues.
• Liaise with Procurement function to develop and execute Supplier Development and Manage Supplier Change Requests.
• Review and approval of development of Incoming Inspection criteria
Title: Compliance Consultant - Validation/Engineering Department – Sandoz, Wilson NC.
• 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
Title: Compliance Consultant Project Manager-Validation Group, Hospira Rocky Mount NC.
• Participated in ‘Due-Diligence’ and 483 Site Remediation strategies; developed Validation Master Plans and Corporate Validation Compliance Transition Plans
5/09 to 6/10: Becton and Dickinson (BD), Wilson, NC
Title: Lead Quality Auditor – Quality Assurance; Packaging Engineering
• 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 and approved qualification documents (FAT, SAT, IQ, OQ, PQ Protocols)
• 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)
6/05 to 5/09: Adecco (consulting services provided):
• Title: Validation/Engineering Consultant - Novartis, Holy Springs, NC
o Supported Quality Operations and QC Management with method transfers of new products to the new Biopharmaceutical Novartis facility
o Reviewed/Approved C&Q (FAT, SAT) and Validation Protocols (IQ, OQ, PQ, Summary Reports)
o Assisted in the design of the QMS (Change Control, CAPA)
o Participated in second and third party audits
• Title: Quality Engineer - Banner Pharmacaps, High Point, NC
o Performed designated Quality Representative functions in R&D and commercial areas (laboratory, validation, vendor audits, and internal regulatory inspections)
o Directed complex technical and/or organizational problem solving activities and encapsulation process and method improvement using statistical analysis tools
o Responsible for identifying negative trends in quality compliance resolving deficiencies through CAPA analysis
o Reviewed product development to ensure collection of appropriate data for regulatory submissions and regulatory compliance
o Planned and prepared complex regulatory submission documents for US regulatory filings and participated in global regulatory teams, interpreting regulations
o Conducted Mock FDA Audits and Pre-Audit Preparations
o
• Title: Validation Engineer Consultant - BIOMERIEUX INC, Durham, NC
o Supervised 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
o Integrated input from the Functions represented by the Project Team to reach a joint solution which maximized business value and met technical objectives
o Managed Project risks and mitigated plans within the Project Leader
o Mapped validation activities to enhance the environmental program of the site, ensuring corrective actions were implemented
• Title: QARA Compliance Consultant - BOIRON Pharma, Newtown Square, PA
o Managed Project risks and mitigated risk assessments interacting at all organizational functional levels reporting directly to company’s VP and CEO
o 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
o Participated in FDA regulatory inspections, investigations, and inquiries regarding the control and assessment of product quality and manufacturing consistency
o Participated 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 a voluntary product recall action as part of the regulatory submission process
Title: Senior Analytical Chemist
• Responsible for Laboratory Equipment Validation:
o HVAC, Fume Hoods, Bio-Cabinets, Glove boxes
o HPLC, GC, AA, Spectrophotometers
o Software – LIMS, Pinnacle Millennium, Agilent/HPChemStation
o Detectors, FTIR, UV Vis, Diode Array, Gas Flame, MassSpec
o Conducted 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; QDMS/Documentum/r-Docs; SAP; Trackwise, LIMS, WATS, ISOTrain; Atlas, QDMS, AutoCAD; Empower2, 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 and Romanian
Contact this candidate