Orbion Pharmaceuticals - Technology Transfer Role

Qualification : M.Pharm/PG

Job Description:

- Responsible for executing and monitoring of trial, scale up, exhibit and validation batches manufacturing for solid orals (Tablets, Capsules, Pellets and Liquid orals)

- Prepare summary report for the batches manufactured.

- Co-ordinate with R&D, Production and other CFT for smooth transfer of Technology from exhibit batch to production scale-up.

- To follow the standard operating procedures and safety precautions.

- Trouble shooting activities to be performed (if any) during the manufacturing of exhibit batches, validation / commercial batches.

- To support in activities related to manufacturing feasibility verification.

- Design and develop technology transfer protocols and other protocols (Sampling , Stability and other related protocols ) for different dosage forms.

- To finalize the batch size for scale up, exhibit, commercial batches and provide bill of materials & quantities.

- To evaluate gap analysis for manufacturing at external site and provide risk assessment for the same.

- To evaluate feasibility changes in product life cycle management.

- To prepare, review and approve Hold time protocols and hold time reports

- To provide justification reports for OOS, OOT, Deviation and Temporary changes with respect to Exhibit, Commercial manufacturing.

- To prepare Technology Transfer Dossier.