. Senior Executive Analytical QA

Roles & Responsibilities

1. Responsible for monitoring of basic norms of cGMP, ALCOA+ Principle, data integrity, GDP & to maintain his personal health hygiene.

2. To review and approve the analytical reports for raw materials, packing material, In-process, Finished product and release or reject raw materials, packing materials, In-process and finished product in the Supply Chain Management system.

3. To review and approve/reject the Certificate of Analysis of RM, PM & finished product.

4. To perform audit trial review for QC & Microbiology instrument CDS and non CDS.

5. To handle different types of activity in SCM, New LIMS, HRMS, Mysetu, Newtronics ICDS 3.1, DMS, EDMS, LMS, Empower , AMS Software,etc.

6. To Prepare, review and control of the Standard operating procedures.

7. Review, issuance and control of analytical documents received from CQA and RA including the specification and test methods for Raw and packing materials, intermediate and FP.

8. To review activities related to chemical and microbiology analysis and perform In process checks in Quality control Laboratory (QC & Microbiology) and ensure GLP is followed in QC.

9. To provide cGMP, GDP and different types of training to employees working in departmental & cross functioned department and ensure that the required initial and continuing training of the departmental personnel is carried out and adopted according to need and maintain record.

10. To receive, review and approve the Analytical reports for stability worksheet, water analysis report and packing material and release or reject packing materials in the SCM.

11. To review and approve/reject the Certificate of Analysis of water analysis and filled stability worksheet.

12. Stability study sample management and monitoring stability chambers. Make entries in LIMS (SCM) for preparation of stability scheduler.

13. To Prepare and Execute stability protocol.

14. To conduct Self Inspection Audit in other department.

Preferred candidate profile

Candidate with relevant experience in formulation industry can share their profile on

sanjay.hrtrp @vsinternational.co.in