Assistant Manager

5 - 7 years

5 - 8 Lacs

Posted:4 hours ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

  • To perform the Technology transfer of Product from R&D to Site

receiving activities and QMS related activities at the manufacturing plant

.  

  • To perform alternate vendor batch execution, process improvement, change in batch size, trouble shooting at shop floor, equipment change activities of product after technology transfer completion along with production team. 

  • To finalize batch sizes of scale up, exhibit and commercial batches to meet the equipment capacities and regulatory requirements with consent of R&D and production. 

  • To prepare/review relevant documents like SOP, Batch Manufacturing Record, Sampling Protocol, hold time study protocol/ report, stability study protocol/report, Process validation protocol and Report for the scale up, exhibit and validation batches. 

  • To provide technical support for change management, investigations of deviations or OOS, CAPA identification and QMS related activities at plant.

  • Ensure cGMP and Regulatory compliance. 

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