senior stability analyst
Hizon Laboratories Inc
Total des années d'expérience :10 years, 3 Mois
Jul 2003 - Feb 2013 (9 years 7 months) senior stability analyst Hizon Laboratories Inc.
Monthly Salary PHP 25, 000
RESPONSIBILITIES: 1. Performs physical analyses ( including description of appearance, hardness, disintegration time, moisture/water content & friability) of new products and stability samples.
2. Performs chemical assays/analyses using HPLC, UV-vis spectrophotometer and FTIR on new products and stability samples.
3. Conducts OOS and OOT investigation on samples undergoing stability testing when results deviate or not within specification.
4. Reviews assay validation and cleaning validation procedure, performs analysis and prepares reports.
5. Prepares and standardizes volumetric solutions following the US pharmacopeia.
6. Conducts dissolution profile test and prepares summary report.
7. Conducts process validation test and method transfer validation and prepares reports.
7. Examines feasibility of analytical test methods.
9. Calibrates simple laboratory instruments and equipment according to their SOPs.
10. Monitors temperature and humidity of stability chambers when needed.
11. Performs OOS investigation on out of specification results and prepares reports for the conducted OOS analysis.
12. Attends cGMP's and SOP's trainings conducted inside the company.
13. Trains new analyst about the protocols, SOP's and safety in the laboratory.
KNOWLEDGE/EXPERIENCE GAINED: Through the years of using HPLC in analyses of drug components, I have been trained to troubleshoot some common problems encountered in HPLC. I have familiarize myself in the columns used in chromtography and how to properly take care of it to lengthen its shelf life. I have attended seminars about HPLCs regarding some techniques on how to obtain a good resolution on our drug analyses.
Nov 2002 - May 2003 (6 months) laboratory technician United Laboratories Inc.
Monthly Salary PHP 9, 000
RESPONSIBILITIES:
1. Assists senior analyst in physical and chemical analyses of drug components.
2. Prepares final reports regarding the assay result of the drug components.
Major B.S. Biochemistry CGPA 80.0/100
University of Santo Tomas Bachelor's, Pharmacy (2002) PR Philippines
2002 University of Santo Tomas Bachelor's/College Degree in Pharmacy/Pharmacology | Philippines