Role: Commission & Qualify (as per Regulatory requirements) Systems / Equipment's / Plants conforming to pre-Approved Site Acceptance Test (SAT) Protocols at Customer's Site Education Qualification: Graduation/PG (Engineering/Biotech/Chemical) Years of Experience: 4 to 6 years Accountable and Responsible for : Coordinate with clients for SAT activities; SAT plans and execution. Coordinate with team for site/service issues. Resolve site issues & provide necessary guidance. Able to Review of site activities with given schedule and escalate if getting delayed. Site cost Management & Drive and Participate in Continuous improvement processes. Team management - resource planning, appraisal, training, grievance handling. Commissioning, Site Piping, Installation & Qualification Validation Protocols (SAT), IQ/OQ System & Equipment Validation, Process Validation Risk Management, Compliance Testing, Functional & Performance Testing Documentation & Change Control (NCR). Regulatory Compliance (FDA, EMA) Deadlegs, Slope, ASME BPE Code, EU Guidelines for C&Q 4 Stages of Equipment Qualification & CSV of System Audit Trail, CIP/SIP, Sterile Industry/Formulation Carrying Out: Installation & Qualification Equipment Qualification Process Validation OQ & CSV (Computer System Validation) Preparing: Change Control Management, NCR (Non-Conformance Report) Documentation & Reporting Site Schedule (IQ & OQ) Show more Show less

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