Role & responsibilities
Strictly follow Positive Documentation Practices and relevant SOPs during work.
Prepare technology transfer documentation for new products and refer dossier documents such as MFR and MPR.
Correct documents such as BMR, BPR and GAP analysis comparison studies as per department head instructions.
Take final prints of customer-approved documents and obtain signatures from responsible stakeholders.
Transfer final customer-approved documents to QA.
Carry out other activities assigned by the Technology Transfer Head from time to time.
Prepare reports such as Scale-up Batch, Exhibit Batch and Trial Batch and complete QMS activities.
Initiate Change Control for current products as per production plan and related QMS activities.
Coordinate with Interdepartmental teams including Production, QA, QC and Packaging Development.
Follow up on Document Review and Approval.




Coordinate current product validation batches, scale-up batches and exhibit batches on the shop floor or F&D; as per requirements.
Prepare and execute trial batches, review BMRs, analyse observations and finalize validation documents.
Resolve technical problems occurring during manufacturing of drug products.
Prepare risk assessments for new products and finalize tablet/capsule product change parts or tooling.
Finalize BOM of new products and upload it into the ERP system.

Preferred candidate profile

Should have worked under MS&T;/Technology Transfer department

Should be comfortable working in shifts

Should be comfortable working in regulated plant setup

📌 Technology Transfer Officer Khopoli (India)
🏢 Qualigens Pharma
📍 India