Quality Assurance Lead - Validation

Winwire Technologies; Bengaluru; On-site; INR 1,400,000 - 2,000,000; Full time

Job summary

Winwire Technologies is seeking a Quality Assurance Lead – Validation in Bengaluru to ensure that all processes and IT systems meet safety and quality standards. This role manages the IQ/OQ/PQ lifecycle and performs risk assessments while serving as the primary expert during audits.

The ideal candidate will have 8-12 years of experience in validation processes and will lead teams to ensure compliance across various systems and processes. Strong communication and leadership skills are essential for this position.

Qualifications

• 8-12 years of experience in validation processes and IT systems.
• Proven track record in managing the IQ/OQ/PQ lifecycle.
• Strong leadership skills in guiding validation teams and collaborating cross-functionally.

Responsibilities

• Ensure compliance with safety and quality standards.
• Lead validation strategy and execution for computerized systems.
• Prepare for audits by providing documented proof of compliance.

Skills

Validation Strategy & Governance

Validation Execution & Documentation

Compliance & Audit Readiness

Testing & Validation Expertise

Familiarity with ACORD Life & Annuity data standards

Effective Communication

Interpersonal Skills

Problem-Solving

Analytical Thinking

Job description

Quality Assurance Lead – Validation

Experience: 8–12 years

Location: Bangalore/Hyderabad

Role Summary: Validation Lead should ensure all processes and IT systems consistently meet safety and quality standards. They manage the IQ/OQ/PQ lifecycle and perform risk assessments to maintain strict regulatory compliance with agencies like the FDA. Ultimately, they serve as the primary expert during audits, providing the documented proof required to guarantee patient safety and product integrity.

Must‑Have Skills

• Validation Strategy & Governance (7+ Years) – Develop and maintain Validation Master Plans (VMP) and lead risk‑based validation strategies aligned with regulatory requirements, business objectives, and project timelines for computerized systems (CSV) and processes
• Validation Execution & Documentation (7+ Years) – Author, review, and approve validation lifecycle documentation including URS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, test scripts, and validation summary reports for systems, equipment, processes, and clinical/usability validation activities
• Compliance & Audit Readiness (7+ Years) – Ensure compliance with GxP, 21 CFR Part 11, CSA, and Data Integrity requirements while partnering with QA teams to support audit readiness, inspection preparedness, deviation/CAPA management, and validation compliance across systems, utilities, and methods
• Testing & Validation Expertise (7–8+ Years) – Drive testing and validation activities for medium to large‑scale implementations including SaaS and Cloud‑based systems using Waterfall, Agile, and Iterative methodologies with strong focus on risk‑based testing and CSV best practices
• Familiarity with ACORD Life & Annuity data standards and insurance domain concepts (Policy, Claims, Actuarial, Reinsurance)
• Communicate effectively with internal and customer stakeholders (technical and non‑technical)
• Strong interpersonal skills to build and maintain productive relationships with team members
• Problem‑Solving and Analytical Thinking
• Capability to troubleshoot and resolve issues efficiently
• Analytical mindset

Leadership & Cross‑Functional Collaboration (3+ Years in Leadership Role) – Lead, mentor, and collaborate with validation teams, business stakeholders, QA, IT teams, vendors, and external partners to ensure high‑quality deliverables, stakeholder alignment, and successful project execution within timelines.