Senior Officer Quality
SMY Pharmaceutical Co., ltd
مجموع سنوات الخبرة :4 years, 3 أشهر
Qualification of Equipment & Instrument including document qualification, user requirement specification, DQ, OQ, IQ, PQ, vendor qualification, requirement traceability matrix, calibration, and preventive maintenance schedules.
Calibration of Equipment and Instrument - Semi-micro and precision balance, Potentiometric Titrator, Karl-fisher Titrator, FT-IR, Dissolution, HPLC, pH meter and conductivity meter.
Reviewer activity - Review of analytical data for raw material analysis, in-process material analysis finished product analysis, Water Analysis, calibration data, draft specification & Standard Test Procedure as per GDP & GLP.
Handling of HPLC - Operating Waters HPLC with empower 3 software for calibration experience and testing experience.
Documentation Activity - preparation of SOP, handling of incidents/ OOS/ OOC, planning of sampling, analysis and releasing of RM, PM, IP, FP, preparation of stability data and trends report. Supervising chemical, standard and column management.
Sampling all type of Raw & Packaging Material, microbial swab, water sampling & Air sampling (active and passive).
Microbial Enumeration testing of primary packaging materials & purified water including TPC & Yeast and mold.
Analysis for all type of raw material and packaging material including HPLC analysis, UV analysis, FTIR Identification, TOC Analysis, Karl fisher analysis, potential metric titration, LOD, ROI, pH, Conductivity, TLC, Melting point, Heavy Metal, Arsenic, Sulphur dioxide, volumetric Titration, Disintegration, Bulk Density, Tap Density, Sieve Analysis, as per USP, BP & EP.
Understanding GLP, GDP, GCP, GMP as per guideline of USP and EDQM guideline.
Preparing SOP, specification, Standard Test Procedure & Analytical Test Method.
Self-Planning for Sampling & Testing Schedule as per condition of retested or expiry date and released date.
Experience in Demonstration by auditing of ANAB Lab for ISO 17025:2017 certification.
Graduated with final year GPA 3.34