Job Description
Key Responsibilities
• Compliance IT for Clinical Research:
• Ensure the proper implementation, documentation, and maintenance of validated IT systems in compliance with regulatory standards (e.g., GxP, 21 CFR Part 11, FDA regulations, ISO standards).
• Oversee and execute Computer System Validation (CSV) activities for clinical applications and laboratory equipment, ensuring adherence to regulatory requirements.
• Manage the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes for lab equipment and IT systems.
• Work closely with regulatory teams to ensure all systems are validated and meet internal and external audit requirements.
• Maintain records of validation activities, deviations, and remediation efforts.
• Core IT Infrastructure and Support:
• Oversee the setup, configuration, and management of servers, including monitoring, patching, and troubleshooting to ensure optimal performance and security.
• Provide end-user support for both hardware and software issues, including new installations, system updates, and troubleshooting networking problems.
• Troubleshoot and resolve network connectivity issues, including LAN/WAN, VPN, and Wi-Fi problems.
• Manage and monitor the organization’s firewall and network security to protect against cyber threats and maintain compliance.
• Collaborate with other departments to plan and implement IT solutions to support clinical research activities.
• System Monitoring and Maintenance:
• Ensure regular backup and disaster recovery procedures for critical systems.
• Maintain up-to-date documentation for all IT systems, networks, and infrastructure in compliance with industry standards.
• Perform system upgrades and patch management for both core IT infrastructure and compliance systems.
• Manage asset lifecycle, from procurement to retirement, ensuring compliance with regulatory requirements.
• Collaboration and Communication:
• Work closely with cross-functional teams, including quality assurance, regulatory affairs, and laboratory management, to ensure IT compliance across all systems.
• Prepare and present technical reports for management and regulatory bodies during audits and inspections.
• Assist in training staff on IT systems and compliance-related protocols.
Qualifications
• Bachelor's degree in Information Technology, Computer Science, or a related field.
• Minimum of 2-6 years of experience in IT roles within the clinical research, pharmaceutical, or healthcare industry.
• Hands-on experience with compliance activities, including CSV, IQ, OQ, PQ, and regulatory audits.
• Strong understanding of GxP, 21 CFR Part 11, and other industry standards relevant to clinical research.
• Proficiency in server management, network administration, and troubleshooting.
• Experience with IT security tools, firewall configuration, and user support.
• Familiarity with clinical research systems, lab equipment, and software applications.
• Excellent problem-solving skills and the ability to work under pressure in a fast-paced environment.
• Strong communication skills with the ability to convey technical concepts to non-technical staff.
Preferred Skills:.
• Knowledge with cloud-based infrastructure and solutions.
• Knowledge of laboratory equipment validation and software used in clinical research.
• Compliance IT for Clinical Research:
• Ensure the proper implementation, documentation, and maintenance of validated IT systems in compliance with regulatory standards (e.g., GxP, 21 CFR Part 11, FDA regulations, ISO standards).
• Oversee and execute Computer System Validation (CSV) activities for clinical applications and laboratory equipment, ensuring adherence to regulatory requirements.
• Manage the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes for lab equipment and IT systems.
• Work closely with regulatory teams to ensure all systems are validated and meet internal and external audit requirements.
• Maintain records of validation activities, deviations, and remediation efforts.
• Core IT Infrastructure and Support:
• Oversee the setup, configuration, and management of servers, including monitoring, patching, and troubleshooting to ensure optimal performance and security.
• Provide end-user support for both hardware and software issues, including new installations, system updates, and troubleshooting networking problems.
• Troubleshoot and resolve network connectivity issues, including LAN/WAN, VPN, and Wi-Fi problems.
• Manage and monitor the organization’s firewall and network security to protect against cyber threats and maintain compliance.
• Collaborate with other departments to plan and implement IT solutions to support clinical research activities.
• System Monitoring and Maintenance:
• Ensure regular backup and disaster recovery procedures for critical systems.
• Maintain up-to-date documentation for all IT systems, networks, and infrastructure in compliance with industry standards.
• Perform system upgrades and patch management for both core IT infrastructure and compliance systems.
• Manage asset lifecycle, from procurement to retirement, ensuring compliance with regulatory requirements.
• Collaboration and Communication:
• Work closely with cross-functional teams, including quality assurance, regulatory affairs, and laboratory management, to ensure IT compliance across all systems.
• Prepare and present technical reports for management and regulatory bodies during audits and inspections.
• Assist in training staff on IT systems and compliance-related protocols.
Qualifications
• Bachelor's degree in Information Technology, Computer Science, or a related field.
• Minimum of 2-6 years of experience in IT roles within the clinical research, pharmaceutical, or healthcare industry.
• Hands-on experience with compliance activities, including CSV, IQ, OQ, PQ, and regulatory audits.
• Strong understanding of GxP, 21 CFR Part 11, and other industry standards relevant to clinical research.
• Proficiency in server management, network administration, and troubleshooting.
• Experience with IT security tools, firewall configuration, and user support.
• Familiarity with clinical research systems, lab equipment, and software applications.
• Excellent problem-solving skills and the ability to work under pressure in a fast-paced environment.
• Strong communication skills with the ability to convey technical concepts to non-technical staff.
Preferred Skills:.
• Knowledge with cloud-based infrastructure and solutions.
• Knowledge of laboratory equipment validation and software used in clinical research.
💡 Quick Summary
Seeking a career-building opportunity? The IT Support Engineer- Compliance position is now open for candidates interested in the IT Engineer & Developer Jobs sector. This role in Ahmedabad offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in IT Engineer & Developer Jobs is a plus.