27 Aug
|
ALS Global
|
Hyderabad
27 Aug
ALS Global
Hyderabad
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 syste
📌 Executive/Senior Executive (Hyderabad)
🏢 ALS Global
📍 Hyderabad