Executive - Quality Control

PeopleStrong; India; On-site; INR 600,000 - 1,200,000; Full time

Job summary

PeopleStrong in India is seeking a Quality Control stability specialist responsible for reviewing analytical reports of finished products and stability samples in LabWare LIMS, ensuring data integrity and audit trails.

You will manage stability chamber operations, prepare data sheets and graphical stability study outputs, review reports by batch, coordinate with production, and ensure GMP compliance through calibration, documentation, and audits.

Responsibilities

• review analytical reports of finished product/semi-finished samples tested in QC in LabWare LIMS
• review stability/RM/Micro/FG & other samples in QC in LabWare LIMS
• carry out stability management activities & ensure proper working of stability chambers
• prepare stability study data sheet and graphical stability study data
• review stability study analytical reports and filing of reports as per batch number
• ensure timely testing of stability samples as per frequency
• investigate QC incidents/OOS/OOT/market complaints
• ensure safety, good documentation practice and GMP in QC
• coordinate with production plan
• internal & external audit compliance
• calibration/validation/AMC activity of stability chambers
• proper handling and cleaning of instruments
• electronic signature on data
• review audit trail records of instruments
• sample management related to Stability Section
• other tasks as assigned by Head QC

Job description

• 1. 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.
• 2. To review the analytical reports of Stability/RM/Micro/FG & other samples tested in Quality Control dept. in LabWare LIMS.
• 3. To review the electronic data, as well as audit trail.
• 4. To carry out all the stability management activities & ensure proper working of stability chambers.
• 5. To prepare stability study data sheet and graphical stability study data of stability sample.
• 6. Review of stability study analytical reports and filing of reports as per batch number.
• 7. To ensure for charging and withdrawal of stability samples as per schedule.
• 8. To ensure on time completion of testing for stability samples as per frequency.
• 9. Investigate the QC Incidents/OOS/OOT/Market complaint or any other investigations.
• 10. Ensure safety, good documentation practice and GMP (Laboratories Control) in QC.
• 11. Responsible for any Internal & External Audit compliance.
• 12. To ensure all the activities related to stability documentation.
• 13. Calibration/Validation/AMC activity of all stability chambers complete with in time scheduled.
• 14. To ensure proper handling and Cleaning of HPLC, dissolution apparatus and other instrument/ equipment.
• 15. Electronic signature (Sign-off 2) on UV, HPLC and GC data etc.
• 16. Review audit trial records of instruments.
• 17. Responsible for sample management related to Stability Section.
• 18. Coordinate with respective department for production plan.
• 19. Other activity/work assigned by Head QC and his designee.