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10.0 - 15.0 years
18 - 30 Lacs
pune
Work from Office
Position Overview: The Position includes key responsibility of management, support, and continuous improvement of GMP-compliant enterprise IT systems critical to pharmaceutical manufacturing and quality assurance processes. This role requires 10-15 years of experience with a strong background in OT and CSV, focusing on applications such as Quality Management Systems (QMS), Track and Trace, Document Management Systems (DMS), Laboratory Information Management Systems (LIMS), Manufacturing Execution System (MES) and other GMP enterprise systems. The candidate will lead the global IT OT team, ensuring compliance with regulatory standards while driving digital transformation initiatives. Key Resp...
Posted 2 weeks ago
2 - 4 years
4 - 6 Lacs
Hyderabad
Work from Office
Provide IT support to QC, Production, AD, and Engineering departments for daily operations, audits, and validations. Coordinate and support CSV (Computer System Validation) activities for software, lab instruments, and manufacturing systems. Administer and manage Active Directory, user access controls, system privileges, and security as per IT GMP requirements. Support and manage IT infrastructure and applications in controlled environments including LIMS, CDS, EMS, BMS, SCADA, and MES. Prepare and maintain documentation like IQ/OQ/PQ protocols, SOPs, Risk Assessments, and Audit Trails. Liaise with QA and regulatory teams to ensure compliance with 21 CFR Part 11, GAMP, EU Annex 11, and Data ...
Posted 5 months ago
4.0 - 7.0 years
5 - 8 Lacs
hyderabad
Work from Office
Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.
Posted Date not available
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