Waleska Delgado Marcano

Experience

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  Schering

  Jun 2004 - Jan 2005

  Regulatory Compliance Sr Manager

  In charge of Complaints, Annual Product Review, Stability, Regulatory Inspections including Suppliers & Commitment Tracking areas.

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  GSK Cidra Puerto Rico

  Jan 2005 - Jan 2009

  QA Manager

  In charge of batch record review process, finished product disposition, Incoming Inspection, Document Control & Chemistry Laboratory Investigation Quality System.

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  GlaxoSmithKline

  Sept 2005 - Sept 2009

  QA Manager

  In charge of batch record review, product disposition, incoming inspection and documentation center, as well of review & approval of analytical laboratory investigation.

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  Independent Consultant for the Quantic Group, Ltd.

  May 2011 - Sept 2018

  Quality Systems Independent Consultant
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  WADELMAR Professional Services

  Jan 2013 - now

  Senior Consultant

  Working on a highly regulatory environment on medical devices,pharmaceutical or API's companies. Supporting Client needs by means of Quality Systems remediation or performing internal & external audits. Re-engineering of Quality Systems such as; complaints, investigations/ CAPAs, product disposition, Annual Product Review (APR); among others. Supporting from QA perspective activities related to research & development for products and analytical methods.

• 

  Mylan, LLC

  Jan 2013 - Sept 2013

  Director Regulatory Affairs & Compliance

  In charge of Change Control, complaints investigations, documentation, Annual Product Review, Supplier Qualification, Internal Audits and Training Quality Systems.Administrator of the Central Archive, Stability Program, batch records, specifications and analytical & microbiological test methods.

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  KALES Consulting, LLC

  Jan 2019 - May 2019

  CAPA Coach

  CAPA Coach

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  KALES Consulting, LLC

  Oct 2019 - now

  Senior Quality Systems Consultant