QC /Regulatory/IP Analyst

Job / Vacancy Code : EMPV579204V

Experience
Minimum 2- 3 years
Work Level
Senior Level
Employee Type
Full Time
Salary/Stipend
Job / Vacancy Locations
:  
Bangalore
Referral Website
:  
Number of Vacancies
:  
01
Date of Posting
:  
31-07-2023
Date of Start of Employment
:  
05-08-2023
Key Skills
:  
I. Candidate shall be minimum “Graduate” with science background and a strong knowledge in statistics II. Atleast 2 – 3 years exposure in handling IP related jobs. Exposure to QC and Regulatory settings in a biomedical/Pharma background will be desirable and could be of great advantage III. Should be conversant with the requirements and protocols of ISO 13485/2016, CE certification and its effective application in an manufacturing setup across company departments. IV. Knowledge in working on CRM and ERP is desirable. V. Develop Sop’s, validation reports, accept/reject criteria for hardware, consumables, and reagents thereof VI. Undertake the root cause analysis for the complaints related to reagents, system/process VII. Undertake training to the team of engineers, supporting staff on these aspects of quality testing VIII. Responsible for quality compliance of all assembly lines and the processes. IX. Shall have strong documentation exposure on all aspects of work. X. Extensive QC t
Address
:  
Dfine Bio-Innovations Pvt LTd,Karnataka,Bangalore,560034
Description
:  

I. Candidate shall be minimum “Graduate” with science background and a strong knowledge in statistics II. Atleast 2 – 3 years exposure in handling IP related jobs. Exposure to QC and Regulatory settings in a biomedical/Pharma background will be desirable and could be of great advantage III. Should be conversant with the requirements and protocols of ISO 13485/2016, CE certification and its effective application in an manufacturing setup across company departments. IV. Knowledge in working on CRM and ERP is desirable. V. Develop Sop’s, validation reports, accept/reject criteria for hardware, consumables, and reagents thereof VI. Undertake the root cause analysis for the complaints related to reagents, system/process VII. Undertake training to the team of engineers, supporting staff on these aspects of quality testing VIII. Responsible for quality compliance of all assembly lines and the processes. IX. Shall have strong documentation exposure on all aspects of work. X. Extensive QC testing for all batches of product goods & approve/ disapprove for market release.

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