Tanmay Behera Email and Phone Number

Provide Leadership in Developing and Implementing the Quality system in Formulation R&D. Ensure that Product Quality is achieved throughout the development stages from Ideation stage till Filing and deficiency addressal.Established the system and procedures in R&D in compliance with Quality guidelines, Regulatory audits and Product development requirements. Sharing of Knowledge and development activities to Manufacturing units during Technology Transfer.Handling Quality notifications in Exhibit batch campaign related to development activities.Support for FDA audits at Manufacturing plants.Review on Pre-Commercialization improvement activities. CAPA, Root Cause Analysis, Training.

Initiation and Implementation of Quality system in R&D, upgrading the overall Quality as per updated guidelines and regulatory requirements on a timely basis.Strategize the Quality need at Ideation stage of product development, till commercialization thro’ scalability and exhibit batch following the QbD concept.Implementation of Electronic documentation practices in R&D as well as manufacturing operations.Experienced and Implementation on different quality aspects in R&D with prime focus on Quality Risk Management, Quality by Design, Failure Investigation, Root cause Analysis, OOS/Incident Investigation, CMC review of ANDA, Facility audits, Handling regulatory deficiency, Regulatory audits.Audit of CROs and CMOs for product development activities followed by manufacturing. Review of activities at those sites for products.Review on Technology transfer for In-house and External CMOs. Building organizational quality in products at external manufacturing sites. Review on Method validation and Transfer to sites.Work on FDA audits at R&D.

Quality assurance in R&D and Manufacturing activity.Review of Product Development activity and documents along with review of exhibit batch documents.

Review and Clearance of Manufacturing Batch record, Line Clearance, Sampling.Review on batch production record and analytical data, Batch release, Area qualification.