At ALS, we encourage you to dream big.
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.
Key Responsibilities
Establish, implement, maintain, and continuously improve IT Quality Assurance systems across laboratory computerized systems.
Lead Computerized System Validation (CSV) activities throughout the system lifecycle.
Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity (ALCOA++), and applicable GxP requirements.
Administer and support laboratory software applications including Waters Empower, Agilent OpenLab CDS & ECM, Thermo Chromeleon, MassHunter, and other instrument software.
Review and approve computerized system validation documents, SOPs, protocols, reports, change controls, deviations, CAPAs, and risk assessments.
Perform periodic review and verification of validated computerized systems to ensure continued compliance.
Review and manage user access, role-based permissions, password controls, electronic signatures, audit trails,
and account management for QMS softwares.
Verify implementation of desktop hardening, operating system security policies, antivirus protection, USB restrictions, firewall controls, and file/folder access controls for GxP systems.
Ensure implementation and monitoring of backup, restore, disaster recovery, archival, and business continuity procedures for computerized systems.
Review audit trails, system logs, event logs, and electronic records to ensure data integrity and compliance.
Coordinate software installation, upgrades, patches, version control, and periodic maintenance activities with IT and vendors.
Support qualification and validation of laboratory instruments, servers, databases, virtual environments, and network infrastructure from an IT QA perspective.
Participate in qualification of laboratory applications including DMS, QMS, LIMS, ELN, inventory systems, and monitoring systems.
Perform supplier assessm
📌 Executive/Senior Executive (Hyderabad)
🏢 ALS
📍 Hyderabad