Company: Solvitall Research Labs Private Limited
Location: Pallikaranai, Chennai
Department: Information Technology / Administration
Experience: 2–5 Years
Employment Type: Full-Time

Key Responsibilities1. IT Infrastructure & Administration

- Manage the overall IT infrastructure of the laboratory, including desktops, laptops, servers, network devices, printers, scanners, and other IT assets.
- Install, configure, maintain, and troubleshoot hardware, operating systems, software, and network-related issues.
- Manage LAN/WAN, Wi-Fi, internet connectivity, switches, routers, firewalls, and other network infrastructure.
- Maintain IT asset inventory, software licenses, warranties, AMC/CMC records, and related documentation.
- Coordinate with external IT vendors and service providers for installation, maintenance, troubleshooting, and support.
- Ensure timely resolution of IT incidents and user support requests.

2. Pharmaceutical Laboratory / cGMP IT Support

- Provide IT support for analytical laboratory instruments and associated computerized systems.
- Support laboratory systems such as Chromatography Data Systems (CDS), instrument software, analytical data systems, and other GxP computerized systems, as applicable.
- Understand the basic principles of cGMP, GLP, data integrity, ALCOA+, electronic records, and electronic signatures.
- Ensure IT systems are operated and maintained in accordance with approved SOPs and applicable regulatory requirements.
- Support implementation and maintenance of controls for user access, password management, audit trails, data backup, data retention, and system security.
- Assist in computerized system qualification/validation activities, including URS, risk assessment, IQ/OQ/PQ, validation documentation, and periodic review, where applicable.
- Support investigation of IT/system-related incidents, errors, access issues, and data integrity concerns.
- Ensure appropriate documentation and traceability of IT activities performed on GxP systems.

3. Data Integrity & Security

- Implement and maintain appropriate controls to protect laboratory and business data from unauthorized access, alteration, loss, or deletion.
- Manage user accounts, roles, privileges, access rights, and periodic access reviews.
- Ensure appropriate backup and restoration procedures are implemented and periodically verified.
- Monitor antivirus/endpoint protection, firewall, security updates, and system patches.
- Support controls related to ALCOA+ principles and data integrity.
- Assist QA in reviewing audit trails and computerized system-related records when required.
- Ensure appropriate controls are established for removable media, external storage devices, and data transfer.

4. Backup, Disaster Recovery & Business Continuity





- Maintain and monitor routine backups of critical systems and data.
- Periodically verify backup integrity and restoration capability.
- Support preparation and implementation of Disaster Recovery (DR) and Business Continuity arrangements for critical IT systems.
- Maintain documented backup, restoration, and recovery records.

5. Computerized System Validation (CSV)

- Coordinate with QA and laboratory personnel for qualification/validation of GxP computerized systems.
- Support preparation/review of:
- User Requirement Specifications (URS)
- Functional/technical specifications
- Risk assessments
- Validation/qualification protocols
- IQ/OQ/PQ documentation
- System configuration records
- User access matrices
- Backup and restoration verification
- Periodic review documentation
- Ensure changes to GxP computerized systems are managed through the approved change control process.
- Support system decommissioning and data archival activities.

6. IT Documentation & Compliance

- Prepare and maintain IT-related SOPs, work instructions, forms, logs, and records.
- Maintain documentation for hardware/software installation, configuration, maintenance, backup, access management, and system changes.
- Ensure IT records are complete, accurate, contemporaneous, attributable, and traceable.
- Support internal, customer, regulatory, and third-party audits related to IT and computerized systems.
- Provide appropriate evidence and records during audits and inspections.

7. User Support & Training

- Provide first-level IT support to laboratory, QA, QC, R&D;, and administrative personnel.
- Conduct basic user training on IT security, password practices, data handling, backup, cybersecurity, and applicable computerized system procedures.
- Support user onboarding and employee exit processes, including creation, modification, and timely disabling of user accounts.

Required Technical Skills

- Windows operating systems and Microsoft Office 365.
- Basic server administration and networking.
- LAN/WAN, TCP/IP, DNS, DHCP, Wi-Fi, switches, and routers.
- Hardware troubleshooting and preventive maintenance.
- Antivirus, endpoint security, firewall, and patch management.
- Backup and restoration systems.
- User account and access management.
- Basic database/system administration knowledge.
- Experience supporting laboratory instruments and/or scientific software will be an advantage.




- Familiarity with CDS, ELN, instrument data systems, or other laboratory computerized systems is preferred.

cGMP / Regulatory Knowledge

Candidates should have a working understanding of:

- Pharmaceutical cGMP / GLP requirements
- Data Integrity and ALCOA+ principles
- Electronic records and electronic signatures
- Audit trail concepts
- User access and privilege management
- Computerized System Validation (CSV)
- Risk-based approach to computerized systems
- Change control, deviation, CAPA, and incident management
- Backup, archival, and data retention requirements
- 21 CFR Part 11 concepts
- EU GMP Annex 11 concepts
- Relevant PIC/S / WHO GMP expectations for computerized systems

Practical experience in a pharmaceutical manufacturing, QC laboratory, analytical R&D; laboratory, CRO, or other GxP-regulated environment will be highly preferred.

Qualification

Essential:

- B.E./B.Tech./B.Sc./BCA/MCA or equivalent qualification in Information Technology, Computer Science, Electronics, or a related discipline.

Experience:

- 2–5 years of relevant IT administration experience.
- Experience in a pharmaceutical, biotechnology, CRO, analytical laboratory, or other regulated environment is preferred.

Preferred Candidate Profile

- Strong troubleshooting and problem-solving skills.
- Good understanding of IT security and data integrity.
- Ability to work closely with QA, QC, R&D;, laboratory and administrative teams.
- Good documentation and record-keeping skills.
- Ability to understand and follow SOPs and GxP requirements.
- Positive communication and interpersonal skills.
- Ability to coordinate with external vendors and service providers.
- Proactive approach to identifying IT risks and system vulnerabilities.
- Willingness to support audits and regulatory/customer inspections.
- Ability to work independently while maintaining compliance with approved procedures.

Key Performance Areas

The selected candidate will be responsible for ensuring:

- Reliable and uninterrupted IT support to laboratory operations.
- Appropriate security and controlled access to computerized systems.
- Effective backup and recovery of critical laboratory data.
- Compliance of IT activities with applicable cGMP and data integrity requirements.
- Timely resolution and documented closure of IT incidents.
- Proper maintenance of IT infrastructure and assets.
- Adequate support for computerized system qualification/validation.
- Audit readiness of IT systems and associated documentation.

How to Apply

Interested candidates meeting the above criteria may share their updated CV with details to mail id: [email protected]

Whatsapp: +91-XXXXXXXXXX

Pay: ₹30,000.00 - ₹60,000.00 per month

Work Location: In person

📌 IT Executive – Pharmaceutical Analytical R&D Laboratory (Chennai)
🏢 Solvitall Research Labs Private
📍 Chennai