Margaret Foley – QA 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.