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Pfizer
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Associate - Quality Assurance

Associate - Quality Assurance

Pfizer

4 - 6 years

5 - 6 Lacs

Visakhapatnam

Posted:1 day ago| Platform:

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Skills Required

Basic Manager Quality Assurance SAP Document review Compliance Associate Quality Assurance Yellow Belt Manager Quality Control HPLC Analytical method validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preferred Education/ Qualification:- B.Pharm/M.Pharm/M.Sc

Experience:- 4 6 years of experience in Quality Assurance / Quality control .

1. Responsible to review the Quality control documents.

2. Fundamental knowledge on Quality control activities.

3. Technical document review skills.

4. Handling of change control assessment and approval

5. Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship.

6. Acts Decisively: Makes decision in a timely manner based on available information

7. Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives

8. Critical thinking and Compliance mindset.

9. Good performance, partially independent, reviews trends and data.

10. Responsible for review of Quality control documents (Analytical Method Validation documents, SOPs, Forms, Stability documents review and approval. Stability trend data and etc.,) to meet current regulatory requirements.

11. Coordinating with CFT for addressing & resolving of Review Comments for timely Closure.

12. Should have trouble shooting abilities in quality control area, which helps the organization to develop, implement and achieve its mission, vision and values.

13. Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime and increase the Efficiency.

14. Report any non-compliance to the Supervisor

15. Should be aware of operation of eQMS change Mangement process.

16. Basic knowledge on gLIMS, SAP, EDES, EAMS.

17. Basic knowledge QRA process.

18. Experience on handling of HPLC, GC, ICP-MS and other instruments.

19. Critical thinking to identify the potential issues in the process.

20. Good to have yellow belt certification.

Work Location Assignment: On Premise

Quality Assurance and Control

#LI-PFE

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Associate - Quality Assurance