| CSV Validation Lead/ Solution Architect || Remote at Princeton, New Jersey, USA |
| Email: [email protected] |
| Greeting, Hope doing well My name is Ankit Kumar, a Sr. Technical Recruiter with Silverlink Technologies. We are looking for a suitable candidate for the position, I came across your resume and found this a perfect fit for this role. I would appreciate it if you can provide the best time and number to reach you to discuss this further Role- CSV Validation Lead/ Solution Architect Location- Princeton NJ or remote Experience: 12+ years Job Title/Role CSV Validation Solution Architect 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 Client Interview Needed for Selection (Yes / No) Y Job Description Job Qualifications- Validation Lead (Onshore): Must have Skills12-15 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. 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 Ankit Kumar Team Lead [email protected] 646-902-6002 https://www.linkedin.com/in/ankit-kumar-6300111a1/ Silverlink Technologies Pvt Ltd www.silverlinktechnologies.com -- Keywords: information technology New Jersey CSV Validation Lead/ Solution Architect || Remote [email protected] |
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| Fri Nov 01 20:34:00 UTC 2024 |