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? _10_ yrs. of Professional experience and strong knowledge with real time experience in areas stated above
? IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
? Well versed with Manufacturing, Quality and engineering system and their validations
? Stakeholder management and good executor with required communication.
? Knowledge of Pharmaceutical / Life Sciences as domain.
? Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage
? Expert in commissioning, qualification, and validation activities for manufacturing project of sterile products, ensuring compliance with plans, requirements, and regulations.
? Having fair understanding to support PLC HMI based equipment instrument qualification
? Industry automation and Instrumentation exposure inline to ISA95
? Design and implement robust validation strategies, author detailed protocols, and prepare comprehensive validation reports for new and existing processes.
? Provide technical guidance during technology transfer activities, troubleshooting, and scaling up of processes to meet manufacturing requirements.
? Conduct thorough risk assessments for manufacturing processes and develop mitigation strategies to address identified risks