Mary S.
Senior Pharmaceutical Quality Control & Assurance Specialist | Biotechnology | FDA, ICH, GxP Compliance Consultant | Six Sigma | Expert in QMS, Environmental Monitoring & Equipment Validation | Scientific Researcher
- Role
- Qa Monitor Validation Specialist at Temdaniels Consulting
- Location
- Richmond, TX, US
- LinkedIn followers
- 500 followers
About Mary S.
Accomplished Pharmaceutical Quality Control / Assurance Specialist with 7+ years of…
Experience
Qa Monitor Validation Specialist
Nov 2024 — Present
Involved in activities such as Corrective and Preventative Action (CAPA), Lab Investigations, Change Control, Out of Specification and Deviations using assistance from the TrackWise system and Veeva.• Managed the validation processes for SAP ERP and LIMS implementation projects, writing and carrying out more than 45 IQ/OQ/PQ protocols.• Achieved compliance at the highest level with GAMP 5 and FDA 21 CFR Part 11, which led to three successful regulatory audits without any critical findings.• Worked with QA, IT, and manufacturing staff to ensure data integrity and electronic records systems.• Aided in legacy system remediation to ensure data integrity requirements.• Enhanced documentation accuracy through electronic management of validation, boosting efficiency by 25%.
Education
Federal University of Technology Akure
Bachelor of Technology (B.Tech)
Health Coach Institute
Health Coach Certificate
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.