QA & Compliance senior specialist
Delta pharma
مجموع سنوات الخبرة :11 years, 11 أشهر
• Documents and records control authorize the distribution, archival, retention and destruction of controlled documents.
• MOH inspector visit & follow up for (FP-API) and coordinate with RA for complete all pending document (NODCAR -Stability-comparative) required for Releasing product.
• Batch Review & Release (Sterile & Non-sterile batches)
• Review (C.O.A) of FP According to NODCAR.
• Follow up quarantine area & daily release
• Share in Site Master File (SMF).
• Investigate and respond to customer complaints & Follow up according to established deadlines company and GMP requirements.
• Perform and implement "change control" in different department as Quality control, production, ware house and more, follow up and track required actions.
• Responsible for reporting of finished product KPIs (Key Performance Indicator).
• Manage Deviation report follow up & archive it.
• OOS follow up
• Internal audit Administer and coordinate internal audits including developing, coordination of audit schedule, identify audit team members, conduct audit and identifying repeated findings.
• External Audit Part from the team that deals with ISO, MOH audit and other external Audit.
• Follow up steps of production according to batch record and conform from batch by IPC sampling from batch at different steps of manufacturing to comply with specification limit in (Semi-Solid, Liquid and Solid areas).
• Implement, maintain and review Pharmaceutical good manufacture Procedures (GMP), Production, Work instructions and records in Production.
diploma in bio chemistry & analytical chemistry
B.Sc. may2009, in Chemistry Faculty of science-Cairo University Grade: Accumulated very Good