16 Oct
|
Valence Labs
|
Patiala
16 Oct
Valence Labs
Patiala
Role & responsibilities
A. IT Infrastructure & Operations
- Manage servers, virtualization, storage, networks, firewalls, Wi-Fi, and endpoint systems.
- Administer Windows servers, Active Directory, DNS, DHCP, user access, and cloud applications.
- Ensure system availability, performance, cybersecurity, backup, and disaster recovery.
- Manage IT helpdesk, incident resolution, change management, and end-user support.
- Coordinate IT projects, vendor management, infrastructure upgrades, and asset lifecycle management.
B. Computerized System Validation (CSV) & Compliance
- Lead CSV activities for GxP systems, including ERP, LIMS, QMS, and other regulated applications, as applicable.
- Prepare and maintain URS, risk assessments, validation protocols, IQ/OQ/PQ, traceability matrices, and validation reports, as applicable.
- Ensure computerized systems remain validated and in a state of control throughout their lifecycle.
- Ensure compliance with FDA 21 CFR Part 11, GAMP 5, data integrity, and applicable GxP requirements.
- Coordinate with QA, system owners, process owners, and vendors for validation, change control, deviations, and CAPA.
- Support internal audits, customer audits, and regulatory inspections by maintaining validation and IT compliance records.
C. Information Security & Governance
- Implement access controls, user account reviews, vulnerability management,
and information security practices.
- Ensure backup restoration testing, business continuity, and disaster recovery readiness.
- Develop and maintain IT SOPs, technical documentation, asset records, and vendor qualification documents.
- Conduct periodic reviews of computerized systems and ensure timely closure of compliance gaps.
Preferred candidate profile
Bachelors degree in IT, Computer Science, or a related discipline.
- Experience in IT infrastructure management and CSV in a pharmaceutical or GxP-regulated workplace.
- Knowledge of networking, servers, cybersecurity, backup, and disaster recovery.
- Hands-on expertise in GAMP 5, 21 CFR Part 11, data integrity, validation documentation, and audit support.
Role: Hardware and Networks - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Engineering - Hardware & Networks, Employment Type: Full Time, Permanent Role Category: Hardware and Networks - Other Education UG: B.Com in Computer Science, B.Tech / B.E. in Any Specialization, B.C.A. in Any Specialization PG: PG Diploma in Computers Key Skills Skills highlighted with ‘‘ are preferred keyskills Hardware NetworkingCSVNetwork TroubleshootingComputer System Validation LAN TroubleshootingDesktop EngineeringInformation SecurityAccess Control
📌 Assistant Manager / Dy Manager - IT (Patiala)
🏢 Valence Labs
📍 Patiala