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Purpose - To review documents and monitor manufacture scale up and exhibit batches for smooth transfer of pharmaceutical formulations from R&D; to manufacturing site.

Position / Job Title - Sr. Officer/Executive

Department - Technology Transfer

Reporting To - GM- Tech transfer

Location - Pithampur (Madhya Pradesh)

Years of Experience - 3-5 Years

Dosage Form - Solid Orals

Job Responsibilities / Deliverables

1.Documentation

Preparation of the batch size documents based on availability of manufacturing equipment with optimum capacity utilization

Preparation of MB02 budget based on complexity of molecule.

Review of Master formula card and Master packing card

Review of protocols like process optimization protocol, process evaluation protocol, process validation protocol, hold time protocol, Product transfer protocol

Review of reports like Process optimization reports, process evaluation reports, process validation report, hold time report, product transfer report.

Evaluate the process of current product and recommend parameters based on scaleup factor calculation for exhibit and intended BMR preparation.

- Batch Execution

Coordinate and monitor scale-up, exhibit, and process validation batches at the manufacturing site.

Ensure all process parameters, in-process checks,



and critical control points are followed as per approved protocols.

Identify process challenges during execution and coordinate with concerned departments for resolution.

- Coordination & Cross-Functional Support

Act as a center point of contact between R&D;, Product Development, Manufacturing, QA, QC, Warehouse, and Engineering for smooth and timely execution of batches.

Arrange all necessary prerequisites, materials, equipment, and utilities prior to batch execution.

Ensure timely communication of project status, deviations, and results to stakeholders.

Coordinate with QC AD team for analytical data of samples collected as per protocol

- Change Control & Investigations

Initiate, track, and ensure timely closure of Change Controls related to product or process transfers.

Compile and analyze process data required for investigations, deviations, and CAPA activities.

Qualifications & Pre-Requisites

M Pharm (Pharmaceutics)

Knowledge of unit operations involved in manufacturing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation etc.

Basic knowledge of QMS (change control, deviation etc.)

Additional notes - Role is expected to work in all shifts.

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