Project Description

Margaret Foley

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Margaret Foley – Q.A. Compliance and Validation Professional

With over 30 years pharmaceutical and medical device experience, Margaret Foley is a highly qualified Quality Assurance, Regulatory Affairs and Validation Specialist.  She is an extremely organized and pragmatic individual with excellent communication skills.

Margaret has a great reputation for delivering projects on time, meeting and exceeding client’s expectations.  She is adaptable with a wealth of experience in API, Oral Solid Dose and Medical Device industries.

Skills and Experience:

Quality System implementation including:

  • Regulatory Affairs specialist.
  • Preparation of Quality Manual & Standard operating procedures
  • Investigation of Customer Complaints, Deviations & OOS
  • Document Control
  • CGMP and Quality System Training
  • Internal & Supplier Audits (Lead Assessor)
  • Preparation & Support during Regulatory Inspections
  • Corrective and Preventive Actions
  • Batch Record Review and Product Release
  • Change Control
  • Regulatory Affairs support including preparation of APRs / PQRs and regulatory submissions
  • Validation & Qualification processes including document preparation, protocol execution and remediation following gap analysis

Examples of Projects Completed:

  • Devise and implement site systems procedures for a new OSD plant in preparation for regulatory inspections.
  • Prepare a Site Master File for a new plant.
  • Prepare Quality Agreements with the suppliers of materials for use in Oral Solid Dose manufacture.
  • Review customer complaints and deviations and perform gap analysis.
  • Review executed Validation Documentation, perform gap analyses, prepare remediation validation protocols to close the gaps, and co-ordinate the
    execution of the protocols.
  • Update and streamline cleaning procedures / cleaning batch records
  • Validation specialist.
  • Regulatory support within Medical Device industry and training of regulatory teams.

Information

LOCATION

Located in Limerick, Margaret can work within a 100km radius of Limerick (Clare, Cork, Tipperary, Galway).

AVAILABILITY

Available Q4 2019.