Harvijaysinh Zala

About Harvijaysinh Zala

My self Harvijaysinh Zala with 16+ years of experience (at Jan 2024) in various…

Experience

1. Assistant Manager

   Chiron Behring

   May 2019 — Present · Anklesvar, IN

   QMS documentation experienceo Handling of QMS activities like Change Control, Deviation, CAPA, Quality Risk Management (Pre and post), Tech transfer documents, process validation documents, SOPs, BMRs, Quality impact assessment, campaign change documents related to production activities.o Vendor qualification documents like URS preparation, DQ documents, FAT documents, SAT documents, IQ, OQ and PQ documents.o Certified lead investigator for major and critical deviations and mentor for critical deviation to make certification of new investigator.o Process Validation protocol and report for process change, newly added raw materials, area modification.o Responsible for internal, external and corporate audit compliance.Monkey pox virus Vaccine development experience:o Preparation of documents for toxicology batches.o GMP manufacturing of monkey pox vaccine DS and DP in R&D labCorona vaccine manufacturing experience:o Establish process of COVAXIN DS manufacturing at CBVPL plant with technology transfer from BBIL.o Preparation of tech transfer documents like SOPs and BMRs.o Inactivation kinetics of SARS-CoV-2 virus inactivation with BPL.Rabies vaccine manufacturing experience:o Responsible for internal (self-inspection of area) and external audit compliance within GMP facility.o Responsible for target fulfilment of shop floor activities without compromising product quality and safety.o Planning: Production budget, batch planning, resource allocation and inventory management.o Responsible to ensure the compliance of QMS activities within manufacturing operations.

Education

• M. N. Virani Science College

  Master's degree

  2005 — 2007

Skills

• Management
• V&V
• Gmp
• Biotechnology
• Manufacturing
• Sop
• Validation
• Quality Assurance