Reviewer
- To review the analytical reports of finished product/semi-finished (Blend/Core/
Coated/Hold time & process validation) samples tested in QC dept. in LabWare LIMS.
- To review the analytical reports of Stability/RM/Micro/FG & other samples tested in Quality Control dept. in LabWare LIMS.
- To review the electronic data, as well as audit trail.
- To carry out all the stability management activities & ensure proper working of stability chambers.
- To prepare stability study data sheet and graphical stability study data of stability sample.
- Review of stability study analytical reports and filing of reports as per batch number.
- To ensure for charging and withdrawal of stability samples as per schedule.
- To ensure on time completion of testing for stability samples as per frequency.
- Investigate the QC Incidents/OOS/OOT/Market complaint or any other investigations.
- Ensure safety,
positive documentation practice and GMP (Laboratories Control) in QC.
- Responsible for any Internal & External Audit compliance.
- To ensure all the activities related to stability documentation.
- Calibration/Validation/AMC activity of all stability chambers complete with in time scheduled.
- To ensure proper handling and Cleaning of HPLC, dissolution apparatus and other instrument/ equipment.
- Electronic signature (Sign-off 2) on UV, HPLC and GC data etc.
- Review audit trial records of instruments.
- Responsible for sample management related to Stability Section.
- Coordinate with respective department for production plan.
- Other activity/work assigned by Head QC and his designee.
📌 Executive - Quality Control (Baddi)
🏢 USV
📍 Baddi