Specialist-IT (Laboratory Systems & Compliance)

Role Purpose The incumbent will be responsible for managing and supporting IT operations for laboratory instruments and standalone systems used in QC and R&D laboratories, ensuring regulatory compliance, system availability, data integrity, and audit readiness in a pharmaceutical manufacturing environment. Primary Responsibilities - Manage day-to-day IT operations for laboratory instruments and standalone systems in QC & R&D laboratories, including but not limited to Empower, OpenLab, IC-DAS, FTIR, UV, LCMS, Auto-titrator, GC, and GC-HS. - Ensure effective backup management, disaster recovery planning, and IT security controls for laboratory and standalone systems. - Support and manage regulatory audits, including preparation, review, and maintenance of required IT and system-related documentation. - Provide hands-on administration and support of VMware virtualization platforms. - Ensure compliance with GxP guidelines, 21 CFR Part 11, Data Integrity principles, and other applicable pharmaceutical regulatory requirements. - Troubleshoot complex system issues with strong problem-solving skills and coordinate effectively with OEM vendors, service providers, and internal stakeholders. - Administer Active Directory and Domain Controller activities, including user management, group policies, access controls, and security restrictions. Additional Responsibilities - Prepare, review, and maintain SOPs, IT policies, and system documentation in line with regulatory and company standards. - Manage and document Change Control, Deviations, CAPA, and Risk Assessments related to IT and laboratory systems. - Support periodic reviews, system validations, and compliance activities as per quality and regulatory requirements. - Ensure continuous improvement in IT processes and system reliability within laboratory environments. Qualifications & Experience - Bachelor’s degree in Information Technology, Computer Science, or related discipline. - 3-6 years of relevant experience in pharmaceutical / regulated industry IT, with hands-on exposure to laboratory systems. - Strong understanding of pharma compliance, audits, and validation concepts. - Experience working with cross-functional teams in QC, R&D, QA, and Engineering is preferred. Key Competencies - Strong analytical and problem-solving skills - Regulatory and compliance mindset - Effective communication and coordination skills - Ability to work independently in a regulated environment

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