Bright Future Pharmaceutical Laboratories, Ltd.
April 2013 — Present
1. Prepare Facility Qualification Plan for existing facilities. This facility qualification plan includes the following attachments:
A. Equipment List
B. System Impact Assessment
C. Qualification Matrix
D. Qualification Plans (Equipment, Process Control Systems and HVAC)
E. Annual qualification Plan
2. Co-author of Validation Master Plan with regard to Qualification
3. Prepare SOPs - Standard Operating Procedure related to QSE-14 Qualification
4. Review qualification documents such as Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification Protocols and Reports
5. Perform Factory Acceptance Tests at equipment manufacturing sites e.g., Germany, Italy, etc.