CSV Validation Lead

Validation Lead

Mandatory

Skills:

CSV/ Compliance and Assurance services/ Validation Testing/ Audit Management/ CAPA and Deviation/ Pharma GxP/ Biopharma and Medical devices/ GAMP5, GxP, 21 CFR Part 11 and Annex 11 compliance

Job Qualifications - Validation Lead:

Must have

Skills:

12-15 years of Validation & Compliance experience. B-Tech/Engineering/MBA 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 & ISO
14971 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.

(1.) To bridge the gap between client needs and business goals by gathering requirements, crafting innovative solutions with deep domain or technology 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 product/project 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 or compliance measures.

(5.) To train and develop team so as to ensure that there is an adequate supply of trained Client in the said technology and delivery risks are mitigated.