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