SENIOR TECHNICAL SPECIALIST - HCL Technologies : Job Details

SENIOR TECHNICAL SPECIALIST

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:

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!

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