CSV Validation Lead
CSV Validation Lead
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Job Description
Hi
Hope you are doing Good!!
This is Priya from S2SSoft LLC we are looking for CSV Validation Lead/ Solution Architect Find the below mentioned job description. Kindly forward me your resume Rate and contact details for further process.
Title : CSV Validation Lead/ Solution Architect
Location : Remote
Type : Contract
Job Description:
Job Qualifications Validation Lead (Onshore):
- Must have Skills1215 years of Validation & Compliance experience.
- BTech/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 problemsolving mentality with strong analytical skills.
Good written and verbal communication skills to effectively communicate with technical and business usersA selfmotivated 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 highperforming team) of innovative solutions for productorproject and sustenance delivery ensuring alignment with strategic objectives.
(3.) To ensure knowledge upgradation 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.
Employment Type
Full Time
