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AG Ganu

Senior Associate

About AG Ganu


AG Ganu  is a Senior Consultant at QualiCulture Consulting Group Consultants who has over 30 years of experience in the pharmaceutical and biotechnology industry. He is an expert in commissioning and qualification of new facilities in compliant manner. He has an extensive engineering background to interpret and apply cGMP regulations relating to a broad range of products and processes. He is instrumental in providing the direction and management of green/brown field projects right from concept to commissioning. 
EXPERTISE:       

  • Provide support to senior management of major- mid-tier and emerging pharmaceutical, biopharmaceutical medical device, dietary supplements and contract organizations companies’ senior management regarding facility designing, commissioning and qualification 
  • Serves as an SME for Designing of Pharmaceutical Utilities - HVAC, Water Systems (Potable Water, Purified Water and Water For Injection), Pure Steam, and Air Systems (Compressed and Nitrogen gas)
  • Provide services for audit of Utility Services, check performance v/s URS, IQ, OQ, PQ documents and report on variance.
  • Provide services for preparation of validation like URS, IQ, OQ, PQ documents and help clients to prepare for Various audits.
  • Standardization of Systems in Engineering Department. 
  • Establishing compliant, cost-effective development and manufacturing facilities
  • Project management ensuring successful project execution on time and within budget
  • Renovation of legacy facilities to support quality compliant flexible, fast and modular manufacturing
  • Applying industry standards for qualification and validation activities
  • Strategies applying the right level of quality compliant automation 
  • Lead more than 20 green/brown field projects (concept to commissioning)related to pharmaceutical biotechnology firms involved in manufacturing of solid oral dosages, vaccines and sterile drug substances and products

EXPERIENCE:        

  • Head - Projects at Biological E Limited
  • Head - Engineering at Ranbaxy Laboratories Limited (Now a Sun Pharma Company) and  Maharashtra Antibiotics & Pharmaceuticals Ltd
  • Worked as an independent consultant  in India and abroad for Bharat Parenterals, PDPL, Phimex Bulk Drugs, Industrial Consulting Bureau Ltd, Doshi Consultants, Sterling & Wilson , Geneal Electric and Airpac Exports Limited etc.  

EDUCATION:    

  • Graduation in Engineering from BITS Pilani

PROFESSIONAL AFFILIATIONS:        

  • Life Member of Indian Institute Of Plant Engineers and ISHRAE – India
  • Life Member of Indian Association of Vaccinology
  • Member of ISPE and International Institute of Validation


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