Job Title

Opening at Cotecna Life Sciences (Pharma vertical). 3+ years of experience in Pharma company/Lab is mandatoryPurpose : To manage, maintain, and ensure compliance of IT infrastructure and computerized systems in alignment with regulatory requirements (e.g., cGMP, USFDA, EU GMP, and data integrity principles). The role is critical in ensuring system availability, data security, backup integrity, and audit readiness.Job Descriptions1. IT Infrastructure ManagementMaintain IT infrastructure including servers, networks, storage systems, and end-user devices.Ensure high availability, performance, and reliability of IT systems supporting GxP operations.Manage user access controls, network security, and system configurations.Coordinate installation, configuration, and maintenance of hardware and software systems.Monitor system performance and troubleshoot issues proactively.2. Backup and Restore ManagementDevelop, implement, and maintain data backup and recovery procedures.Ensure periodic backup of all critical systems (e.g., LIMS, HPLC/LCMS software and other laboratory instrument software).Perform and document backup verification and restoration testing at defined intervals.Maintain logs and evidence of backup activities in compliance with audit requirements.Ensure secure storage and retention of backup media (onsite/offsite/cloud as applicable).3. Computerized Systems Compliance (cGxP)Ensure all computerized systems comply with regulatory requirements such as:USFDA 21 CFR Part 11EU Annex 11Data Integrity (ALCOA+) principlesSupport validation lifecycle activities (as and when required):User Requirement Specifications (URS)IQ/OQ/PQ documentationChange control and periodic reviewMaintain audit trails, system logs, and ensure their periodic review.Ensure role-based access control and prevent unauthorized system access.Participate in internal and external audits and provide required documentation.4. Data Integrity and SecurityImplement and maintain controls to ensure data integrity across all systems.Monitor audit trails in collaboration with Quality assurance for anomalies (e.g., deletions, modifications).Ensure compliance with cybersecurity policies, including antivirus, patch management, and firewall controls.Manage incident response for data breaches or system failures.5. Documentation and SOP ManagementPrepare, review, and update IT-related SOPs, policies, and work instructions.Maintain documentation related to system configurations, backups, validations, and access controls.Ensure all activities are documented in compliance with cGMP requirements.6. Change Management & Incident HandlingManage IT-related changes through formal change control procedures.Investigate and document deviations/incidents related to IT systems.Implement corrective and preventive actions (CAPA) for system-related issues.7. Vendor and System ManagementCoordinate with IT vendors and service providers for system support and maintenance.Ensure vendor compliance with pharmaceutical regulatory expectations.Support procurement and qualification of new IT systems.Experience & Qualifications : 3+ years of relevant experience from Lab/Pharma with Bachelor’s degree in IT, Computer Science, or related field. Certification in IT systems, networking, or cybersecurity (preferred)Key Skills & Competencies : Strong knowledge of cGMP, 21 CFR Part 11, EU Annex 11. Expertise in backup and disaster recovery systems. Ability to handle regulatory audits (USFDA, MHRA, WHO, etc.). Strong documentation and communication skills.Location : Digha (Navi Mumbai)If interested, please share your updated resume on OR for any more information, call on 9870476784.