12 Nov
|
BIOCON BIOLOGICS
|
Bengaluru
12 Nov
BIOCON BIOLOGICS
Bengaluru
Job Description
• Maintain the inventory of all Scientific (R&D;) and QC applications/systems at the respective site.
• Prepare, review, implement, and maintain applicable IT SOPs, procedures, and quality documentation for Scientific and QC systems.
• Provide IT administration and application support, including user/access management, password administration, active-user reviews, date/time management, event-log reviews, backup, restoration, and data retrieval.
• Support GxP computerized system qualification and validation, including 21 CFR Part 11 assessments, periodic reviews, and compliance activities from an IT perspective.
• Coordinate with business teams, Central IT, vendors/OEMs, and service providers for system implementation, breakdown support, troubleshooting, and issue resolution.
• Manage IT-related incidents, deviations, change controls, RCA, CAPA, and audit observations for Scientific and QC systems.
• Represent IT during internal, customer, third-party,
and regulatory audits/inspections, including preparation of required documentation, responses, and supporting evidence.
• Ensure adherence to applicable IT, Quality, GxP, organizational policies, procedures, SLAs, and regulatory requirements.
• Analyse and support implementation of current business/application requirements in coordination with cross-functional teams and management.
• Provide user training and technical guidance during application rollouts and as required.
• Ensure reliable IT support for business-critical, GxP, regulatory, and product/consumer-safety-related systems and services.
• Drive service reviews, process improvements, benchmarking, and continual service improvement for Scientific and QC IT services.
Experience:
5-7 years of experience in IT LIMS
📌 IT - LIMS (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru