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