Hyderabad

Good knowledge on the scale-up factors from RD to EB scale pharmacokinetics of drugs, proficiency in BE studies is required. Experience in responding regulatory Queries for all markets

M.Pharm or Ph.D. in Pharmacy with industrial experience in pharmaceutical development and scale-up of products. Preferred area of expertise is Oral Dosage forms and Injectable formulations. Perform formulation development activities on differentiated formulations and innovative technologies to achieve Product development.

Ensuring all equipment and materials used in the filling process are properly sterilized and sanitized to maintain aseptic conditions and prevent contamination. Quality Assurance, Conducting in-process checks and inspections to verify product integrity, including visual inspections, measurement checks, and sampling for microbiological testing.

Position in the research project Centre for translational research and training on endocrine pancreas and Type 2 diabetes in India. M.Sc,BS-MS,M.Tech in Bioinformatics, Computational Biology, Systems Biology, Biotechnology OR BPharm, MBBS,B.Tech,M.Tech Computer science

Contributes, with appropriate oversight, to all relevant aspects of global clinical trial activities to deliver study outcomes within schedule, budget, quality, compliance and performance standards. May lead specific aspects of global clinical trial. High quality contributions to study documents e.g. protocol, ICF, clinical sections of CTA -Clearly demonstrates Novartis Values and Behaviors i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.

First Class B. Pharmacy and Masters Degree in Pharmacy with a Ph.D. in the relevant branch. Minimum 10 years of teaching, research, industry experience. At least 5 years as an Associate Professor.

Candidates experience in Sterile Quality Assurance, covering QMS, Validation, IPQA, and related areas.

Personnel handling this profile will be responsible for performing reactions as per the requirement of the project. They are also responsible for documenting the observations in relevant note books.

Oversees the development, implementation, and maintenance of the Quality Management System within the Probiotics or Non-Aseptic manufacturing facility. This includes ensuring that all processes, procedures, and documentation comply with relevant regulatory standards such as Good Manufacturing Practices.