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
Job Classification
Industry: Pharmaceutical & Life Sciences
Functional Area / Department: Quality Assurance
Role Category: Business Process Quality
Role: Quality Analyst
Employement Type: Full time
Contact Details:
Company: Pfizer
Location(s): Visakhapatnam
Keyskills:
Basic
Manager Quality Assurance
SAP
Document review
Compliance
Associate Quality Assurance
Yellow Belt
Manager Quality Control
HPLC
Analytical method validation
