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