Job Title Quality Assurance Officer

Department: Quality Assurance

Industry: Sterling Healthcare
Location: Talegaon, Pune
Function: Quality Control Formulation (OSD Plant)
Experience: 24 Years
Qualification: B.pharm. M Pharm

Role & responsibilities

1. Preparation Of quality assurance sop

2. To ensure the quality control compliances by scheduling the day to day activity.

To review primary standard, working standard reference standard management.

To review column management system

To review system suitability solution record.

To review chemical receipt and management record.

To review logbooks.

To ensure qualification record, calibration status and logbooks are properly maintained.

To check random traceability of analysis performed by analyst.

To ensure completeness training schedule of QC personnel.

3. To perform validations of Computer system used in QC instruments, production equipment’s and ERP System, Spreadsheet etc.

4. To identify And evaluate risk Assessment for equipment,



instruments qualification and for validation of computer system as per ICH Q9 Guidelines.

5. To update change regarding the equipment’s or instruments qualification and Computer system validation in csvmp.

6. To identify the change Need in quality control procedure and assist to QC team regarding initiation of change control

7. Charging withdraw of stability Samples as per the relevant stability protocol, master stability scheduled and stability monthly planner

8. Preparation of stability protocol , master stability scheduled and stability monthly planner

9.Maintain the stability chamber equipment’s usage log and reconciliation of stability samples.

10.Maintain the stability study of finished product

11. Daily monitoring and maintenance of temperature and relative humidity records of stability chambers

12. Preventive maintenance and alarm verification of stability chambers.

13.Review of long book and instruments/equipment's calibration report of quality control departm

📌 Quality Assurance Officer (Pune)
🏢 Sterling Healthcare
📍 Pune