HCL Technologies
SOLUTION ARCHITECT
HCL Technologies, Bergen, New York, United States, 14416
Job Description (Posting).
Validation Lead (Onshore)Must have Skills12-15 years of Validation & Compliance experienceB-Tech/Engineering/MBA or equivalent degreeProven experience in Application Maintenance and Development, Validation Testing scope of work, Audit Management , CAPA and DeviationGood understanding of pharma GxP environment and enabling emerging technologies for GxP complianceKnowledge 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 complianceMaintaining customer relationship and manage expectations and escalationCOE Project Management, around Governance, Demand Management, Estimation & Sizing Good to have SkillsProactive and problem-solving mentality with strong analytical skillsGood 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
Validation Lead (Onshore)Must have Skills12-15 years of Validation & Compliance experienceB-Tech/Engineering/MBA or equivalent degreeProven experience in Application Maintenance and Development, Validation Testing scope of work, Audit Management , CAPA and DeviationGood understanding of pharma GxP environment and enabling emerging technologies for GxP complianceKnowledge 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 complianceMaintaining customer relationship and manage expectations and escalationCOE Project Management, around Governance, Demand Management, Estimation & Sizing Good to have SkillsProactive and problem-solving mentality with strong analytical skillsGood 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