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Hands-on experience in monitoring manufacturing and packaging processes, line clearance, and in-process checks. Proficiency in DOC-MS systems, SOP preparation, deviation handling, and change control. Involvement in TT activities including protocol review, execution, and coordination between RCD and manufacturing. Familiarity with validated software systems that meet FDA electronic records and signatures requirements. Robust understanding of equipment qualification (D, I, O, P), process validation, and cleaning validation. E-BMR G E-Log: Experience with electronic Batch Manufacturing Records and Logbooks for real-time documentation and traceability. uality Management Systems (MS): Implementation and maintenance of MS aligned with regulatory standards . Risk Assessment: Ability to conduct and document risk assessments for processes, equipment, and product quality. .