Key Responsibilities

1. Assist the Study Director in the planning, conduct, monitoring, and documentation of in-vivo and in-vitro toxicology studies, including Acute, Sub-acute, Sub-chronic, and Genotoxicity studies.
2. Support the execution of studies in accordance with approved study plans, Standard Operating Procedures (SOPs), GLP principles, and applicable regulatory guidelines.
3. Perform accurate and timely raw data recording and documentation in compliance with GLP requirements.
4. Handle laboratory animals and perform dosing/administration procedures as required for assigned studies, while following approved protocols and animal welfare requirements.
5. Maintain appropriate study-related records, worksheets, observations, and other documentation to ensure data integrity and traceability.
6. Develop a working knowledge of national and international regulatory guidelines applicable to toxicology and safety assessment studies.
7. Assist in the preparation, review, and compilation of study plans, amendments, raw data, and study reports.
8. Coordinate with Study Directors and other study personnel to ensure studies are conducted according to approved timelines and protocols.
9. Identify and promptly communicate any deviations, unexpected observations, or study-related issues to the Study Director.
10. Support general laboratory and study-related activities as assigned.

Required Skills & Competencies

1. Good understanding of Good Laboratory Practice (GLP) principles and their application in non-clinical laboratory studies.
2. Working knowledge of regulatory toxicology studies and relevant national and international guidelines.
3. Practical knowledge of animal handling and dosing techniques is preferred.
4. Ability to accurately document and maintain study-related raw data and records.
5. Good scientific writing and documentation skills.
6. Ability to assist in the preparation of study plans and study reports.

Compensation: As per industry standards and candidate experience.

Key Responsibilities

1. Manage the complete IT infrastructure lifecycle, including requirement gathering, implementation, maintenance, upgrades, and system retirement.
2. Administer analytical instrument software and laboratory computerized systems, including user access, audit trails, and electronic signatures.
3. Provide support for LIMS and other critical laboratory systems, ensuring efficiency and data integrity.
4. Develop and maintain IT policies, SOPs, formats, and compliance documentation.
5. Monitor IT security, audit trails, system logs, backups, and data integrity.
6. Manage backup, restoration, disk cloning, business continuity, and disaster recovery activities.
7. Conduct IT risk assessments and implement appropriate controls to mitigate operational and security risks.
8. Computer System Validation (CSV) activities for critical laboratory and business applications.
9. Coordinate and support internal, client, and regulatory audits, including preparation of required IT/CSV documentation.
10. Provide help desk support, user training, and escalation management.
11. Ensure compliance with applicable GxP, FDA, HIPAA, GDPR, and ISO 27001 & FDA regulations.

Required Skills

1. 5-8 years of relevant experience in IT Infrastructure, Laboratory IT, CSV, or IT Compliance within a regulated environment.
2. Good knowledge of GxP, data integrity, computerized systems, LIMS, and analytical instrument software.
3. Working knowledge of CSV, IT security, backup/DR, risk management, and audit requirements.
4. Strong documentation, troubleshooting, communication, and coordination skills.

Compensation: As per industry standards and candidate experience.