Technology Transfer Officer

Qualigens Pharma; Khopoli; Sur place; INR 600 000 - 900 000; Plein temps

Résumé du poste

Qualigens Pharma in Khopoli, India seeks a Technology Transfer professional to manage documentation, scale-up, and validation activities in a regulated plant.

You will coordinate with Production, QA, QC and Packaging Development, prepare and review batch records and change controls, and ensure timely closure of QMS activities while supporting new product introductions and product changes.

Qualifications

• Should have worked under MS&T/Technology Transfer department
• Should be comfortable working in shifts
• Should be comfortable working in regulated plant setup

Responsabilités

• Follow Good Documentation Practices and 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 new 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 new 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.

Connaissances

MS&T/Technology Transfer

Shift work

Regulated plant environment

Description du poste

Role & responsibilities

• 1. Strictly follow Good Documentation Practices and relevant SOPs during work.
• 2. Prepare technology transfer documentation for new products and refer dossier documents such as MFR and MPR.
• 3. Correct documents such as BMR, BPR and GAP analysis comparison studies as per department head instructions.
• 4. Take final prints of customer-approved documents and obtain signatures from responsible stakeholders.
• 5. Transfer final customer-approved documents to QA.
• 6. Carry out other activities assigned by the Technology Transfer Head from time to time.
• 7. Prepare reports such as Scale-up Batch, Exhibit Batch and Trial Batch and complete QMS activities.
• 8. Initiate Change Control for new products as per production plan and related QMS activities.
• 9. Coordinate with Interdepartmental teams including Production, QA, QC and Packaging Development.
• 10. Follow up on Document Review and Approval.
• 11. Coordinate new product validation batches, scale-up batches and exhibit batches on the shop floor or F&D as per requirements.
• 12. Prepare and execute trial batches, review BMRs, analyse observations and finalize validation documents.
• 13. Resolve technical problems occurring during manufacturing of drug products.
• 14. Prepare risk assessments for new products and finalize tablet/capsule product change parts or tooling.
• 15. 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