Working knowledge of cGMP guidelines, FDA 21 CFR Part 820/210/211, ICH guidelines and other international regulatory requirements. HVAC system Commissioning, control facilities temperature and relative humidity mapping, facilities Qualification and Validation activities.Scheduling, planning and execution of validation projects for plant utilities, facilities and process equipment. Apply thorough understanding of cGXPs, relevant plans and SOPs, routine project procedures, project management activities as appropriate.Plan Commissioning & Qualification activities and track execution of C&Q activities/documentation versus project timeline. Write/review C&Q plans, study/test protocols, and summary reports. Manage execution of study/test protocols and review test results. Commissioning and qualification protocol execution, and manage protocol deviations, investigation and corrective action activities Have excellent analytical skills with systematic approaches to problem solving. Demonstrate ability to comprehend mechanical/electrical drawings and related engineering prints for C&Q activities.The position requires a combination of sedentary work and walking around the cGMP manufacturing facility
Working knowledge of cGMP guidelines, FDA 21 CFR Part 820/210/211, ICH guidelines and other international regulatory requirements.
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