PDL OSD Documentation / Research Associate

Role & responsibilities

1. To maintain and ensure the cGMP compliance.

2. Preparation of MPCR, PVP, PVR, HSP & HSR based on TTD.

3. Preparation of proposed commercial MPCR based on marketing requirements.

4. Raw material tracking for the smooth functioning and timely execution of the products.

5. QMS related activities (CRF/Deviation/Investigation/CAPA) and compliance.

6. Follow up for CRF approval.

7. Creation of HALB code and preparation of BOM in SAP

8. Compilation of validation documents like Process validation report and Hold time study report.

9. Any other job assigned time to time by superiors.

Preferred candidate profile

US Market experience in ANDA filing, CMC documentation, regulatory compliance, and technology transfer.

Perks and benefits

As per company policy