Megha Juneja

I was a part quality team for the production of biosimilars. My key responsibilities included daily checks and walkthroughs of the production floor, reviewing and approving the batches records , providing the data for regulatory filings, investigating and closure of deviations with CAPA implementations, tecnology trasfer and handling of change managements, and ensuring inspection readiness ready participating in National and International Audits such as US FDA, EMA, and ANVISA.

I was heading the Quality Control department and leading a team of 14 members . The unit manufactured diagnostic kits for the detection of infectious diseases such as Malaria, HIV etc. My job responsibility included planning the day to day working of the department, managing and implementing the calibration programme for the department, authoring the SOPs, implementation of the CAPA, designing the stability regime, technology transfer and release the finished product for the market after thorough analysis

Key responsibilities included Batch Manufacturing record review and final closure and In process Quality rounds and support for a biologic producing plant

Biotechnology, Molecular Biology, Immunology and process engineering

Molecular Biology, Immunology, Bioinformatics, Process engineering