Orbion Pharmaceuticals - Technology Transfer Manager

Qualification : M.Pharmacy/PG

Job Description:

- Responsible for execution of Scale-up, Exhibit, Pre-validation, Process verification and Validation batches of oral solid ( Tablets, Capsules, Pellet formulations, Liquid orals).

- To prepare, review and approve Change control, Temporary change, Deviations, OOS (Out of Specification), OOT (Out of Trend), Assessment report/s, Scale up report, justification report/s and other related documents.

- To review and approve master manufacturing records.

- To manufacture lab scale trial batches and process optimization trial batches in R&D.

- Co-ordinate with R&D, Production, Quality Assurance, Analytical R&D, Quality control for smooth transfer of Technology from exhibit batch to Production scale.

- To follow the standard operating procedures and safety precautions.

- Trouble shooting activities to be performed (if any) during the manufacturing of Exhibit batches,

Process Verification / Process Validation / Commercial batches.

- To support in activities related to costing i.e. (COGs) and new or any equipment installation

and qualification purpose.

- To finalize the batch size for Scale-up, Exhibit, Commercial batches and provide Bill of Materials & Quantities (BOMQ).

- To evaluate feasibility changes in product life cycle management.

- To prepare, review and approve Technology Transfer Dossier.

- To evaluate, prepare and approve gap analysis for site transfer batches and provide risk

assessment for the same.

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

- To check preparedness for manufacturing trial batches, Scale up and Exhibit batches.

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

- To finalize the batch size for Scale-up, Exhibit, Commercial batches and provide Bill of Materials &

Quantities (BOMQ).

- To evaluate feasibility changes in product life cycle management.

- To prepare, review and approve Technology Transfer Dossier.

- To evaluate, prepare and approve gap analysis for site transfer batches and provide risk

assessment for the same.

- To check preparedness for manufacturing trial batches, Scale up and Exhibit batches.