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It/csv /di Qa Lead Resume

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West Lebanon, NH

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SUMMARY:

Executive consultant with extensive experience in the pharmaceutical & medical device industry. Specific areas of expertise include: IT/CSV/DI QA SME, project management, information technology, systems validation, inventory accuracy, materials management, and transportation. Expert knowledge of cGMPs and compliance documentation development. People oriented, analytical and innovative. A results oriented executive with broad business scope who operates effectively in a customer driven environment. Excellent interpersonal relations and highly effective working with teams. Ability to handle multiple projects simultaneously and exceed goals in a timely manner.

TECHNICAL SKILLS

  • Successfully achieved computer system validations in FDA regulated Companies
  • Full knowledge of 21 CFR part 11, 21 CFR 820, 21 CFR 210 & 211, Annex 11, GAMP 5
  • Extensive validation lifecycle experience
  • SOP development extensive experience
  • Fluent in English and Spanish (Oral and written)
  • Experience in Cybersecurity, Serialization and data integrity
  • Implementation of complex ERP systems (JDE and SAP)
  • Expert experience in MS office, MS Visio and MS Project software
  • Project Management
  • Experienced in Trackwise, Crystal reports, LIMS and Siemens systems
  • Performed DI Gap Analysis in domestic and international regulated companies

PROFESSIONAL EXPERIENCE

Confidential, CA

Sr. IT / CSV Principal Consultant

Responsibilities:

  • Serve as senior computer system validation lead for team developing IT SOP’s.

Confidential , Cambridge, MA

Sr. IT / CSV Principal Consultant

Responsibilities:

  • Serve as senior computer system validation lead for team developing IT SOP’s.

Confidential, California

IT/CSV /DI QA LEAD (Consultant)

Responsibilities:

Serve as senior computer system validation lead for team performing assessment.

Confidential,

IT/CSV /DI QA LEAD (Consultant)

Responsibilities:

  • Serve as senior computer system validation lead for team performing assessment.

Confidential Duluth, GA

IT/CSV QA LEAD (Consultant)

Confidential , West Lebanon, NH

IT CSV LEAD (Consultant)

Responsibilities:

  • Work with business support department teams to support operation readiness for launch and approval of active ingredient pharmaceutical for hemophilia products.

Confidential , Irvine, CA

IT CSV LEAD (Consultant)

Responsibilities:

  • Lead CSV team to the successful conclusion for the remediation of manufacturing systems in the shop floor.

Confidential , Fort Washington, PA

IT/CSV QA LEAD (Consultant)

Responsibilities:

  • Support site on computer system validation.

Confidential , Foster City, CA

Maximo Validation Engineer (Consultant)

Responsibilities:

Support site on computer system validation for Maximo system.

CareFusion, El Paso, TX

Sr. Computer System Validation QA (Consultant)

Responsibilities:

Advice and support site on computer system validation and compliance.

Confidential, Hamburg, GE

Sr. Computer System (Consultant)

Responsibilities:

Advice and support Q&R and R&D departments on computer system validation and 21 CFR part 11 compliance.

Confidential Guaynabo, PRSr.

Computer System (Consultant)

Responsibilities:

  • Managed project from startup to completion.

Confidential , Anapolis, GO, Brazil

Computer System Validation (Consultant)

Responsibilities:

  • Advice and support QA and Technical Services departments on computer system validation and compliance.

Confidential , Dorado, PR

Business System Analyst (Consultant)

Responsibilities:

  • Extracted data from current systems for new SAP integration with data integrity assessment and test.

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