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CSV Validation Lead at Remote, Remote, USA
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http://bit.ly/4ey8w48
https://jobs.nvoids.com/job_details.jsp?id=1867094&uid=

From:

Arun kumar,

yochana IT

[email protected]

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CSV Validation Lead

Princeton NJ or Remote

Contract

Mandatory Skills CSV/ Compliance and Assurance services/ Validation Testing/ Audit Management/ CAPA and Deviation/ Pharma GxP/ Biopharma and Medical devices/ GAMP5, GxP, 21 CFR Part 11 and Annex 11 compliance

Job Description

Must have Skills 12-15 years of Validation & Compliance experience.

B-Tech/Engineering/MBA or equivalent degree.

Proven experience in Application Maintenance and Development, Validation Testing scope of work, Audit Management , CAPA and Deviation.

Good understanding of pharma GxP environment and enabling emerging technologies for GxP compliance.

Knowledge in establishing standards such as ISO 13485, ISO 9001 & ISO14971 guidelines for Pharmaceuticals, Biopharma and Medical devices in IT service industry.

Understanding of the regulated software development life cycle (SDLC) as per GAMP5, GxP, 21 CFR Part 11 and Annex 11 compliance.

Maintaining customer relationship and manage expectations and escalation COE Project Management, around Governance, Demand Management, Estimation & Sizing.

Keywords: information technology New Jersey
CSV Validation Lead
[email protected]
http://bit.ly/4ey8w48
https://jobs.nvoids.com/job_details.jsp?id=1867094&uid=
[email protected]
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01:53 AM 23-Oct-24


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