Hi,

Hope you are doing well.



This is Ranjith From Themesoft, I was Reviewing your resume regarding to
the Job Opportunity with our Fortune Client. Please Go through the
Following Job Description and let me know of your interest. Don’t Hesitate
Contact me at 408-868-2905.You can also reach me Via Email at
ranjith.vem...@themesoft.com, if you are interested Please reply back to my
email with your updated resume in Word Format.



*Title; Validation Tester*

*Location: SFO, CA*

*Duration: Long term*



*Job Description*

•         Min 6-7 years of Validation Testing experience on native mobile
based applications for Pharma companies.

•         Native mobile application validation on iOS and Android platforms.

•         Life Science Validation Knowledge (21CFR Part 11, GxP).

•         Medical Device Validation in Biopharmaceutical industry.

•         Expertise in documenting Validation Deliverables for life Science
customers.

•         Good knowledge in FDA regulated environment and work experience
in GMP, GCP, GLP and GDP standards and medical device validation as per FDA
21 CFR Part 820.





*Title; Validation Tester*

*Location: Rahway, NJ*

*Duration: long-term*



*Job Description*

• Communicate with the project management team and inform project status,
key decisions and risks/issues on the project

• Interact with Client Project and Program Managers in the implementation
and adherence of CSV Project Methodology

• Produce awareness training on general agency regulations and best
practice methods to improve team knowledge and productivity

• Perform periodic evaluation of validated/qualified state of systems

• Manage and oversee the compliance analysts within a team/account

• Initiate Compliance Improvement Plan and Service Improvement Plan and
track through successful closure

• Provide proactive advice, guidance and support on compliance and quality
requirements to the support teams

• Manage Face-to-Face meetings with Customer Compliance team

• Report  Compliance issues , deviations from QMS and Security breaches due
to non-compliance to the appropriate audience

• Perform monthly self-assurance tests in all applicable process area on
SOx environments to ensure that all controls are in-line with the SOx
requirements

• Share the monthly SOx reports with the SOx control owner for review and
approval

• Participate in the annual design effectiveness review programs and
contribute towards streamlining the SOx controls



*Best Regards,*

Ranjith Vemula

Ph: 408-868-2905 | Email: ranjith.vem...@themesoft.com
<smith...@themesoft.com>

THEMESOFT, INC*. | **www.themesoft.com* <http://www.themesoft.com/>

MBE &WBENC Certified Minority-Woman Owned Business
Celebrating a Decade of Providing Innovative Staffing Solutions

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