About
Aligned Automation

At
Aligned Automation, we live by our "Better
Together" philosophy to build a better world. As a strategic service
provider to Fortune 500 companies, we help digitize enterprise operations and
drive impactful business strategies. Our purpose goes beyond projects—we strive
to deliver meaningful, sustainable change that shapes a more optimistic and
equitable future.

Our
culture is deeply rooted in our 4Cs—Care, Courage, Curiosity,
and Collaboration—ensuring that each employee is empowered to grow,
innovate, and thrive in an inclusive workplace.

Position: QA Testing Lead

Location: Pune, India

Experience Required: 8+ years

Employment Type: Full time

Role Overview

We are seeking an experienced QA Lead to oversee the
testing and validation of GxP/GMP-regulated computerized systems within the
pharmaceutical, biotech, or life sciences domain. The ideal candidate will have
a deep understanding of Computer System Validation (CSV) principles, 21
CFR Part 11, GAMP 5, and Annex 11 regulatory frameworks.

This role involves defining the testing strategy,



managing
QA teams, and ensuring all systems and applications meet compliance, quality,
and business requirements through structured validation and documentation
processes.

Key Responsibilities
- Lead,
mentor, and guide a team of QA testers to ensure timely and high-quality
delivery of validation and testing activities.
- Define
and implement QA strategies, validation frameworks, and best practices for
regulated systems.
- Develop,
review, and approve test plans, protocols (IQ, OQ, PQ), test scripts,
and validation deliverables (RTM, TCR, TSR).
- Ensure
all QA activities comply with GxP, GMP, CSV, and data integrity requirements.
- Collaborate
with Business Analysts, Developers, and Validation teams to ensure
traceability from requirements to testing.
- Drive defect
management and ensure timely resolution of issues with development
teams.
- Participate
in audits and regulatory inspections, providi

📌 QA Testing Lead (Indore)
🏢 Aligned Automation Services
📍 Indore