Job description:

New Billing, Exclusive, Potential
Job Qualifications- Validation Lead (Onshore)
Must have Skills

12-15 years of Validation Compliance experience
B-TechEngineeringMBA 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 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.

• 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/tech expertise to gather client needs, deliver solutions, and craft a technology strategy aligned with business goals.