Group technical architect with Domain Competencies (APPS)-Pharma Validation & Verification-Computer System Validation (CSV) in New Jersey | HCLTech
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Job Description

Group technical architect

Job Summary

  • Location: New Jersey

  • Project role: Group technical architect

  • Qualification: B-Tech

  • Experience: >11 Years

  • Skills: Computer System Validation (CSV)

  • Secondary Skills:
    • CSA AUDIT
    • ISO 27001:2005 ISMS
    • SCIENCES (GXP FDA CSV IQ/OQ/PQ)
    • Compliance and Assurance services
    • Medical Devices

  • No. of positions: 3

Job description:

New Billing, Exclusive, PotentialJob Qualifications- 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.

  • To bridge the gap between client needs and business goals by gathering requirements, crafting innovative solutions with deep domain/technology expertise, and driving successful implementations that propel strategic initiatives.
  • To spearhead the architecture, design, and development (through a high-performing team) of innovative solutions for product/project & sustenance delivery, ensuring alignment with strategic objectives.
  • To ensure knowledge up-gradation and work with new technologies so that the solution is current and meets quality standards and the client requirements
  • To review architecture and design deliverables and ensure solutions adhere to industry best practices ,architectural standards simultaneously establish and enforce governance /compliance measures.
  • 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

Disclaimer

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcltech.com for investigation.

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