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.vemula@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
Ranjith Vemula
Ph: 408-868-2905 | Email: ranjith.vemula@themesoft.com
THEMESOFT, INC. | www.themesoft.com
MBE &WBENC Certified Minority-Woman Owned Business
Celebrating a Decade of Providing Innovative Staffing Solutions
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