Summary This role is the deft in technology transfer of Injectable products to manufacturing plant scale up and demonstrate the technical capability and accessibility to current portfolio and pipeline products The incumbent will also be jointly responsible for achieving targeted product execution goals of department organization He would be responsible for Documentation Evaluation and Monitoring of batches at Manufacturing site To perform product transfer activities of sterile products assigned by Manager Sr Manager Designee Execution Supervision of Trial Engineering Scale-up Submission Exhibit batches To perform activities related to Technology transfer at site As applicable To compile Scale up trials Scale up batches Submission batches results drawing conclusions Prepare technology transfer documents i e Product risk assessment Hold time study protocol report Scale-up batch protocol report etc as applicable Initiation of request for Creation Extension of Material code prepare RM PPM Day to day work on SAP document compliance manager and track wise or other relevant software which are used for documentation work Observance of the laid down standard operating procedure SOP as applicable at all PAR formulation sites including workplace safety To carry out the Literature search on quality management Regulatory Guidance as applicable To Co-ordinate with cross functional teams for the timely completion of assigned activities To work out a project plan specifying timelines and target completion dates To support in documentation for Investigations Deviations Incidents Out Of Specifications Out Of Trends and Non-conformances as applicable to R D To perform work allotted by Manager Sr Manger designee Bachelor of Pharmacy Master of Pharmacy Full Time Required Experience 4 - 8 yrs Good exposure Experience of technology transfer MSAT Technical services Production for regulated market in injectable sterile products Hands on Experience with GMP Documentation activities FDA regulations and guidance s GMP GDP Good communication skills and smart thinker Work in a transparent setting Proactive and Innovative