4.0 - 8.0 years

0 Lacs

indore, madhya pradesh

On-site

This role requires you to be highly skilled in technology transfer of Injectable products to manufacturing plants, including scale-up activities and demonstrating technical capabilities. You will play a key role in ensuring accessibility to both current portfolio and pipeline products. Additionally, you will share responsibility for achieving targeted product execution goals within the department/organization. Your duties will involve documentation, evaluation, and monitoring of batches at the manufacturing site. Your responsibilities will include performing product transfer activities for sterile products as assigned by the Manager/Senior Manager/Designee. You will be involved in the execution and supervision of Trial, Engineering, Scale-up, and Submission/Exhibit batches. You will compile results from scale-up trials, scale-up batches, and submission batches, drawing meaningful conclusions from the data. Moreover, you will be tasked with preparing various technology transfer documents such as Product risk assessment, Hold time study protocol & report, Scale-up batch protocol & report, among others. Your daily tasks will also encompass initiating requests for the creation or extension of Material codes, as well as working with SAP, document compliance manager, and other relevant software for documentation purposes. It is essential that you strictly adhere to the standard operating procedures (SOP) applicable at all PAR formulation sites, ensuring workplace safety. Furthermore, you will be responsible for conducting literature searches on quality management and Regulatory Guidance, as required. Collaboration with cross-functional teams to ensure timely completion of assigned activities is a crucial aspect of this role. You will be expected to develop project plans outlining timelines and target completion dates. Your support in documentation for various investigations, deviations, incidents, Out Of Specifications (OOS), Out Of Trends (OOT), and non-conformances, as applicable to R&D, will be highly valued. Ideally, you should hold a Bachelor's or Master's degree in Pharmacy, with a minimum of 4-8 years of relevant experience. Your exposure and experience in technology transfer, Manufacturing Science and Technology (MSAT), Technical services, and production for regulated markets in injectable/sterile products will be beneficial. Proficiency in GMP documentation activities, FDA regulations, and guidelines is essential. Additionally, strong communication skills, critical thinking abilities, and a proactive, innovative approach to work are key attributes for success in this role.,

Posted 1 day ago

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