13 Aug
|
Aligned Automation Services
|
Indore
13 Aug
Aligned Automation Services
Indore
About the Job
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.
Job Title: Computer System Validation
(CSV) Engineer – Pharmaceutical Manufacturing
Location: Indore
Job Type: Full time
About the Role:
We are seeking an experienced CSV Engineer to
drive the validation and compliance strategy for computerized systems across
the pharmaceutical manufacturing area. This role will be responsible for
ensuring all GxP-regulated systems are validated, tested, and maintained in
compliance with industry regulations including 21 CFR Part 11, EU Annex 11, and
GAMP 5 guidelines.
This role combines leadership in CSV practices with
hands-on Quality Assurance testing oversight, working closely with
cross-functional teams across IT, Quality, Manufacturing, and Engineering.
Key Responsibilities:
Validation Leadership & QA Testing
- Review
and approve SDLC deliverables and validation documentation for
GxP-regulated computerized systems.
- Oversee
the development and execution of validation test plans and test scripts
for system implementations and changes.
- Provide
Quality Assurance leadership in testing activities, including defect
tracking, resolution, retesting, and ensuring complete traceability.
- Review
and approve compliance plans, user requirements, traceability matrices,
and validation summary reports.
- Ensure
proper documentation and rigorous testing practices are followed to meet
audit and inspection readiness standards.
Compliance & Risk Manageme
📌 CSV Engineer (Indore)
🏢 Aligned Automation Services
📍 Indore