I am passionate about quality system and organizational excellence, including;
1) Handling of Management Review Meetings.
2) Preparation of Site Master File.
3) Preparation of Quality Manual.
4) Preparation for ISO Certification ISO 9001, 14001 & 18001.
5) Risk Management & Business Continuity Planning.
6) Change Control & Management.
7) Handling of (1st, 2nd & 3rd Party) Audits.
8) GEMBA walks and cGMP/IPC Follow-up in warehouses and production areas (sterile & non-sterile Penicillin facility + non-β-Lactam facility).
9) Handling of Customer Complaints.
10) Handling of Product Recall
11) CAPA Management.
12) SOPs preparation and up-date.
13) Batch record review and release.
14) Product Q..
I am passionate about quality system and organizational excellence, including;
1) Handling of Management Review Meetings.
2) Preparation of Site Master File.
3) Preparation of Quality Manual.
4) Preparation for ISO Certification ISO 9001, 14001 & 18001.
5) Risk Management & Business Continuity Planning.
6) Change Control & Management.
7) Handling of (1st, 2nd & 3rd Party) Audits.
8) GEMBA walks and cGMP/IPC Follow-up in warehouses and production areas (sterile & non-sterile Penicillin facility + non-β-Lactam facility).
9) Handling of Customer Complaints.
10) Handling of Product Recall
11) CAPA Management.
12) SOPs preparation and up-date.
13) Batch record review and release.
14) Product Q..
