When you join us, you’ll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future.
Job Summary
- Manage and control instrument application privileges and user access.
- Provide IT QA support for analytical instruments and associated software.
- Support and execute Computer System Validation (CSV) activities throughout the system lifecycle.
- Ensure GxP compliance, including data integrity, data security, audit trails, deviations, CAPA, change control, and system verification.
- Participate in regulatory inspections and audits (FDA, NABL, CDSCO, customer audits, etc.).
- Provide site-specific application and IT system support.
- Ensure adherence to site-specific IT and QA SOPs.
- Support instrument qualification activities (IQ, OQ, PQ).
- Perform data backup verification for instruments and periodic software verification every two years.
- Create and manage annual and monthly projects in instrument applications.
- Conduct and manage periodic access reviews for validated system
Job Qualifications
- Strong knowledge of GxP regulations and data integrity principles.
- Hands-on experience in Computer System Validation (CSV).
- Understanding of 21 CFR Part 11 and Annex 11 requirements.
- Experience with analytical instrument software and validated systems.
- Knowledge of DMS, QMS, and firmware-based systems.
- Strong documentation, deviation handling, and CAPA management skills.
- Ability to coordinate effectively with cross-functional teams
- Familiarity with regulatory guidelines such as FDA, EU Annex 11, and data integrity requirements
- Ability to work in a regulated manufacturing and laboratory environment.
- Robust attention to detail and compliance-focused mindset.
- Ability to manage multiple systems and priorities simultaneously.
Working at ALS
The ALS team is a diverse and dedicated community united by our passion to make a difference in the world.
Our val
📌 Executive – IT (Navi Mumbai)
🏢 ALS Global
📍 Navi Mumbai
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