Post graduation diploma
Kurzprofil:
Dear Team,
My name is Koteswara Rao Ankam; I am a Senior Pharmaceutical Production Manager with over 23 years of experience in the GMP-regulated manufacturing of sterile, aseptic, and solid dosage forms. I possess extensive expertise in EU-GMP, FDA 21 CFR, and ICH Q7, combined with a proven track record in preparing for and managing international regulatory inspections.
I have successfully navigated 13 consecutive inspections (including FDA, EMA, WHO, MHRA, and TGA) with no critical or major deviations-clear evidence of the highest quality standards and excellence in compliance. I have in-depth technical knowledge of aseptic manufacturing (fill & finish, lyophilization, terminal sterilization) as well as validation (IQ/OQ/PQ), CAPA management, and root cause analysis.
I am experienced in leading production teams in cleanroom environments (ISO Class 100,000) with a focus on increasing efficiency, process optimization, and fostering a sustainable GMP culture. I am proficient in using digital systems such as SAP, MES, LIMS, and TrackWise to ensure audit-ready documentation and data-driven decision-making.
I currently reside in Munich and hold a valid German work permit. My goal is to secure a responsible position in pharmaceutical production in Germany, focusing on quality, compliance, and operational excellence.
Koteswara Rao Ankam
Mobile: 015510338115