Job Description Summary
This role is the deft in technical services of Injectable products in Packaging and DHF activities and demonstrate 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.Job Description
- To check the product requirements and Design of change parts for appropriate packaging machines.
- Design, compatibility, development, and technical inputs for artwork development with respect to the primary and secondary packaging configuration to line feasibility in coordination with Production
- To provide technical inputs to cross functional team related to the Design controls activities for combination products
- Responsible for preparation, review and approval of the design control documents for combination products i.e PFS etc.
- Assessment of the testing requirements for the Design verification and validation activities of the combination product.
- Preparation, Review and approval of Design verification and validation activities of the combination product protocols and reports.
- To prepare and review the applicable Standard Operating Procedures related to Design Control Documents (DHF).
- Initiation of request for Creation / Extension of Material code and Prepare specification of PPM/SPM.
- To execute compatibility studies for injectable products
- To design secondary package for injectable products.
- Prepare technology transfer documents i.e. Batch Packing Records, Packaging BOM etc. (as applicable).
- To supervise Trial/Engineering, Scale-up, Submission batches, PPQ batches execution at site.
- Bachelor of Pharmacy / Masters of Pharmacy (Full Time)
- Required Experience: 1-3 yrs.
- Good exposure / Experience of DHF activities and technology transfer in packaging for regulated market in injectable / sterile products.
- Hands on Experience with GMP Documentation activities.
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