Executive/Senior Executive

Als; Hyderabad; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

ALS is seeking an IT Quality Assurance professional to lead CSV activities across laboratory computerized systems in Hyderabad. You will ensure robust IT QA processes, maintain validated states, and manage access controls and security for GxP environments.

The role requires coordinating with IT, QA, and vendor teams to sustain compliant systems, perform audits, reviews, and incident investigations, and support customer and regulatory inspections.

Qualifications

• Establish, implement, maintain IT QA systems across laboratory computerized systems.
• Lead Computerized System Validation (CSV) activities through the lifecycle.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements.

Responsibilities

• Administer and support laboratory software applications including CDS and instrument software.
• Review and approve validation documents, SOPs, protocols, reports, deviations, CAPAs.
• Perform periodic review of validated systems to ensure continued compliance.
• Coordinate software installation, upgrades, patches, and maintenance with IT and vendors.
• Support qualification of laboratory instruments, servers, databases, and network infrastructure from an IT QA perspective.

Skills

CSV activities

GxP compliance

Data integrity (ALCOA++)

Audit trails

Tools

Waters Empower

Agilent OpenLab CDS

Thermo Chromeleon

MassHunter

Job description

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 ResponsibilitiesEstablish, 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 assessments and qualification of software vendors and IT service providers.Conduct internal audits, data integrity assessments, and periodic compliance reviews of computerized systems.Review and approve IT-related deviations, change controls, CAPAs, and incident investigations.Ensure all GxP computerized systems remain in a validated state throughout their lifecycle.Develop, review, and maintain IT Quality SOPs, policies, templates, validation master plans, and technical documentation.Coordinate user training on computerized systems, data integrity, cybersecurity awareness, and regulatory requirements.Support customer audits, regulatory inspections, and responses related to computerized systems and IT compliance.Prepare periodic compliance dashboards, KPI reports, validation status reports, and management review inputs.Collaborate with QA, Analytical Operations, Bioanalytical, Engineering, IT Infrastructure, and external vendors to ensure robust computerized system compliance.Perform any additional IT QA responsibilities assigned by the Head.Instrumentation SkillsHands-on experience with Chromatography Data Systems (CDS) such as Waters Empower, Agilent OpenLAB CDS & ECM, Thermo Chromeleon, Mass hunter etc.Understanding of integration between analytical instruments, servers, databases, and networksFamiliarity with backup, archival, disaster recovery, and system security controlsDMS, LIMS, ELN, QMS, and laboratory digital systemsWorking at ALSThe ALS team is a diverse and dedicated community united by our passion to make a difference in the world.Our values are important to us, and shape how we work, how we treat each other and how we recognise excellence.At ALS, you’ll be supported to develop new skills and reach your full potential. We invest in our people with programs and opportunities that help you build a diverse career with us.We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and our communities.Everyone MattersALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued.ALS also welcomes applications from people with all levels of ability. Reasonable adjustments to support candidates throughout the recruitment process are available upon request.EligibilityTo be eligible to work at ALS you must be a Citizen or Permanent Resident of the country you are applying for, or either hold or be able to obtain, a valid working visa.How to applyPlease apply on-line and provide a resume & cover letter that best demonstrate your motivation and ability to meet the requirements of this role.