Jr. Scientist-r&d Technology Transfer Injectable

4 weeks ago

Indore, India Endo International Full time

This role is the deft in technology transfer of R&D 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, QMS activities and monitoring of batches at manufacturing site.
- To perform product transfer activities of injectable and complex injectable assigned by Manager/Sr. Manager /Designee.
- Execution /Supervision of Trial, Engineering/Scale-up & Submission/ Exhibit batches.
- To perform all activities related to Technology transfer at site (As applicable)
- To compile and interpretation of Scale up trials/Scale up batches/Submission batches results, drawing conclusions.
- Prepare & review technology transfer documents i.e. Product risk assessment, Batch manufacturing & packing records, Hold time study protocol & report, Scale-up batch protocol & report etc. (as applicable).
- Handling of QMS documents like Change control, Investigations, Deviation, CAPA, 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.

Education & Experience
- Bachelor of Pharmacy / Masters of Pharmacy (Full Time)
- Required Experience: 8 - 10 yrs.
- Good exposure on technology transfer of Simple & Complex Injectable / sterile products.
- Technology transfer experience for regulated market in simple and complex injectable / sterile products.
- Hands on Experience with GMP Documentation and QMS activities.

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