CQV manager

Main Responsibilities:Be responsible to prepare and review the CQV (Commissioning, Qualification, and Validation) documents of RA, RTM, DQ, FAT, SAT, IQ and OQ for project based on project schedule, communicate with client for documentation updates.Be responsible for project CQV activities organization and implementations, with the ability to independently execute at least one of the following systems: facility and utility validation (water systems, HVAC systems, process gases, etc.), production process equipment and computer system commissioning and qualification.Project risk assessment execution, can handle punch and deviation for CQV activities, can close the punch and deviation based on project procedure and GMP requirement.Participate in the on-site execution of FAT, SAT, IQ, and OQ, and be responsible for reviewing and approving commissioning and qualification protocols and reports.Demonstrate strong communication and coordination skills with suppliers and on-site engineers to resolve related issues based on project progress and quality.Communication capabilities with client for CQV activities, implement CQV activities based on SOP and project schedule.Review project over packages and lead systems handover to client on time.Complete assigned tasks according to project schedule requirements.Job Requirements:At least 5 years commissioning and qualification working experiences in pharmaceutical industry. Can work independently if need and should have the teamwork spirit. Bachelor’s degree, Familiar with the FDA/EMA/WHO GMP and cGMP knowledge and general engineering practice. Familiar with ISPE, ASTM and E2500 and international guidance are preferable. Fluent English communication skill with foreign client. Be able to work under pressures, meet with client and accept overseas business trips.Better have a leadership capability.