Hire Srinivas Rao Chellumala, a pharma consultant specializing in Drug Development, Medical Devices, Pharmaceutical Manufacturing, Pharmaceutical Quality and Sterile Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Srinivas Rao Chellumala is a pharmaceutical and biotechnology consultant with approximately 26 years of experience in vaccine manufacturing, plant operations, and regulatory compliance. His professional background includes roles with Biological E., Shantha Biotechnics, Sanofi Healthcare India, and GCBC Vaccines. Through Sri Srinivasa Healthcare Services, he supports biologics manufacturing, vaccine formulation, aseptic manufacturing, equipment qualification, and process validation. His expertise also covers quality management systems, deviation investigations, GMP compliance, and workforce training. He has managed vaccine production across multiple manufacturing suites and supported WHO, corporate quality, and national regulatory inspections. His consulting work focuses on pre-audit gap assessments, manufacturing documentation, technical investigations, and improvements to operational quality practices. - Show More
Srinivas supports aseptic vaccine manufacturing through operational assessments, procedure reviews, and cleanroom workforce coaching. His experience includes managing formulation and filling suites under cGMP and WHO requirements. He helps clients identify gaps in manufacturing workflows, strengthen SOPs, and improve personnel practices related to cleanroom behavior, hygiene, and operational risk reduction.
Srinivas supports biologics manufacturing with a focus on vaccine drug substance and drug product operations. His experience covers Diphtheria, Pertussis, Tetanus, Hepatitis B, Hib, and Cholera vaccines, including antigen production and the establishment of master and working seed lots for Diphtheria and Pertussis. He helps organizations review manufacturing processes, production workflows, and technical documentation to strengthen vaccine manufacturing operations.
Srinivas supports deviation and failure investigations across vaccine formulation, filling, and packaging operations. He works with manufacturing, engineering, and quality teams to assess technical issues, review investigation findings, and develop corrective and preventive actions. His practical production experience helps connect documented findings with improvements to manufacturing processes and procedures.
Srinivas supports qualification and requalification of equipment used in vaccine formulation, filling, and packaging. His experience includes developing qualification protocols, coordinating maintenance, and supervising installation and commissioning activities. He assists clients in reviewing equipment qualification documentation and aligning qualification activities with intended manufacturing use and operational requirements.
Srinivas provides technical support for vaccine formulation, drawing on experience managing formulation and filling across multiple production suites. His background includes DTP and Tetanus Toxoid vaccine formulation and the introduction of new vaccine manufacturing lines. He supports review of formulation procedures, batch documentation, production planning, and coordination with filling operations to improve manufacturing consistency and efficiency.
Srinivas supports GMP compliance through pre-audit gap assessments, manufacturing practice reviews, and documentation improvements. His experience includes coordinating WHO, corporate quality, and national regulatory inspections. He assists clients with reviewing batch manufacturing records, SOPs, validation protocols, and technical reports to identify deficiencies and strengthen readiness for regulatory scrutiny.
Srinivas provides practical GMP training for manufacturing technicians, production personnel, and operational teams. His experience includes onboarding employees, maintaining training records, and mentoring staff across vaccine manufacturing suites. His training focuses on SOP adherence, manufacturing documentation, cleanroom behavior, and hygiene practices to help teams apply quality requirements consistently.
Srinivas supports process validation activities and documentation for vaccine manufacturing. His experience includes preparing process validation protocols and reviewing batch records and technical reports. Drawing on his background in antigen production, formulation, and filling, he helps clients identify documentation gaps and ensure that validation protocols reflect the manufacturing processes being evaluated.
Srinivas supports the implementation and improvement of quality management systems for pharmaceutical and biotechnology operations. His experience includes managing manufacturing documentation, training systems, failure investigations, and corrective and preventive actions. He helps organizations establish structured quality procedures and investigation frameworks that support consistent operations and inspection readiness.
