Job Description

Job Title: Sr. QA Executive

Department:

QA / QC

Location:

Palghar

Reporting To:

QA Manager

Key Responsibilities:

1.Assigning work allocation to the team member as per production planning

2. Prepare MFR with the help of Technology Transfer Dossier received from R&D Dept.

3. Prepare BMR & BPR as per production planning requirement

4. Prepare instrument calibration and Qualification protocol

5. Preparation and compilation verification of process validation protocols and records

6. Preparation and compilation verification of cleaning validation protocols and records

7. Preparation and compilation verification of Hold time study validation protocols and records

8. Preparation of Qualification / Validation protocol of the Equipment, Systems and process by co-ordination with Production & Engineering Department

9. Ensure the issuance of required documents and samples to Regulatory, Critical Quality Attributes and Purchase Dept. as per requirement.

10. Ensure the preparation, revision/review of revised documents (SOP's, Specification and Protocol) and retrieval of obsolete documents.

11. Investigate the cause of any non-conformance and its corrective / preventive action.

12. Ensure the Analytical method validation of cleaning process before conducting cleaning validation.

13. Cleaning Validation Analytical Data collection and summary report preparation of cleaning validation.

14. Plan and execute process validity activity at the defined frequency

15. Preparation of Audit compliance report within specified period

16. Ensure effective CAPA management system for Internal and external audit compliances.

17. Responsible to evaluate investigation of market complaint with effective implementation of CAPA.

18. Responsible for verification Site Master File, Validation Master Plan, Product Quality Review and Quality Manual

19. Allocation for assigning Batch number to semi-finished and finished product.

20. Preparation of inspection plan for pre-shipment of finished products

21. Execute all aspects of quality assurance activities throughout the development lifecycle

22. Following the SOP and Process.

Key Skills & Competencies:

Good communication and coordination skills. Eye for detail, accuracy in documentation. Leadership and problem-solving skills. Familiarity with

GMP, ISO / audit documentation

preferred.

Qualifications & Experience:

B.Sc / M.Sc / B.Pharm / M.Pharm (preferred)

3-7 years

of experience in

chemical manufacturing industry

.
Job Type: Full-time

Pay: ?25,000.00 - ?41,000.00 per month

Benefits:

Paid sick time Provident Fund
Work Location: In person