Description

Should be responsible for batch release

Monitor stability schedule and ensure analysis is performed timely

Review of Specification and STP

Preparation and review of SOP

Raw Data review review for Finished product batch release

Preparation of various protocols such as stability study, hold time study, photostability study, Freeze thaw study

Participate in OOS/ OOT and deviations investigations and ensure timely closure of the same.

Support RA department by providing all the required documents for product filing

Ensure VQ is done for all RM,PM,API suppliers and maintain record for the same.

Ensure compliance of the AMV laboratory, software qualification of various instruments in AMV lab

Should visit CMO/CTL for data review

Ensure qualification of equipment done

Qualifications

Should have worked in relevant area for at least 5 years

Should be well versed with QC instrument software's, LIMS, QMS software should possess positive analytical skills

Should prepare PPT for meeting and project updates, MRM

Should have faced USFDA, EUGMP, HC and other regulatory inspections independently.

📌 Team Leader (Kukatpally)
🏢 Aveva Drug Delivery Systems
📍 Kukatpally