HCL Technologies
Job Location : Bergen,NY, USA
Posted on : 2024-11-14T06:25:52Z
Job Description :
Job Description (Posting). Role/Responsibilities:- To design and architect large-scale solutions, ensuring scalability, performance, and security.
- 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.
- To continuously upskill with cutting-edge tech to deliver high-quality, future-proof solutions meeting client expectations and industry standards.
- To leverage domain or tech expertise to gather client needs, deliver solutions, and craft a technology strategy aligned with business goals.
Minimum Requirements:- B-Tech/Engineering/MBA or equivalent degree.
- Must have 12-15 years of Validation Compliance experience.
- 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.
Desired Qualifications:- Proactive and problem-solving mentality with strong analytical skills.
- Good written and verbal communication skills to effectively communicate with technical and business users.
- A self-motivated individual with a genuine passion for Compliance Validation Role.
Apply Now!