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Urgent Hiring || CSV Validation Lead || Princeton NJ (Remote) at Princeton, New Jersey, USA
Email: [email protected]
Max rate $60/hr on c2c.

Dear Vendors,

I hope this email finds you well.

My name is Irfan, a Sr. Technical Recruiter in Silverlink Technologies. I wanted to reach out to share an exciting job opportunity at
HCL
.
We are currently seeking a highly skilled and motivated individual for the position of
CSV Validation Lead.

If you or someone you know might be a good fit for this position, I encourage you to review the below job description. If interested, please feel free to reach out to me directly.

Position: CSV Validation Lead

Location: Princeton NJ (Remote)

Client: HCL

Duration: Long Term

Job description:

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

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.

Good to have Skills:

Proactive and problem-solving mentality with strong analytical skills.

Good written and verbal communication skills to effectively communicate with technical and business usersA self-motivated individual with a genuine passion for Compliance & Validation Role.

(1.) To bridge the gap between client needs and business goals by gathering requirements, crafting innovative solutions with deep domainortechnology expertise, and driving successful implementations that propel strategic initiatives.

(2.) To spearhead the architecture, design, and development (through a high-performing team) of innovative solutions for productorproject and sustenance delivery, ensuring alignment with strategic objectives.

(3.) To ensure knowledge up-gradation and work with new technologies so that the solution is current and meets quality standards and the client requirements.

4.) To review architecture and design deliverables and ensure solutions adhere to industry best practices ,architectural standards simultaneously establish and enforce governance orcompliance measures.

(5.) To train and develop team so as to ensure that there is an adequate supply of trained manpower in the said technology and delivery risks are mitigated.

Thanks & Regards

Mohd Irfan

SR.Technical Recruiter

Email:

[email protected]

linkedin.com/in/irfan-ulla-khan-3ba6b916b

Silverlink Technologies

www.silverlinktechnologies.com

LLC

501 Fifth Avenue, Suite 805,

New York, NY 10017

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Keywords: information technology New Jersey New York
Urgent Hiring || CSV Validation Lead || Princeton NJ (Remote)
[email protected]
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Wed Oct 23 01:26:00 UTC 2024

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Location: Princeton, New Jersey