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Xi'an-EMa-Site C&Q CSV Lead
Requisition ID: 1805651966W
Responsible for providing leadership and coordination on C&Q and CSV activities leveraging with both internal and external resources, in context of both capital projects and/or site standard activities.
Accountable to implement C&Q and CSV updated guidelines from relevant CoEs as well as guidance and practical related solutions.
Responsible to present the C&Q and CSV protocols to relevant internal / external GMP authorities, in coordination with the QA lead.
- To constantly and promptly inform on C&Q CSV policies and contribute to the definition of related JNJ's rules and procedures;
- Guarantee correct execution of the C&Q CSV process established by the relevant CoEs by creating and/or updating the local procedures for which it can also be a trainer;
- Coordinate according to the current SOPs the activities necessary for:
- Commissioning, Qualification and CSVs of new equipment and production utilities and laboratories through the drafting of the necessary documentation;
- Requalification of existing production equipment and utilities according to the predefined frequency.
- Participate in the execution of documented surveys for possible deviations from current practices and operating procedures;
- Participate in the specifications of the systems to qualify and coordinate the departments involved in the implementation of the qualification protocols.
- Manage external consultants necessary for the execution of the activities listed above.
- Guarantee a constant professional updating and propose to the Engineering Lead programs and innovations of methodologies and operating procedures in order to constantly improve the skills and abilities of the technical staff of the Site.
- Accountable for ensuring process equipment, utilities and labs equipment are in full compliance with regulatory requirements, company policies and procedures,
- Accountable for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures. This individual will provide compliance leadership, direction and execution in Computer System Validation for the site information systems
- Accountable to present and explain C&Q CSV strategy and documentation to inspectors during GMP/EHS audits
- Facilitate the release of any system functionality updates for GxP production use in line with company timelines. Support the resolution of deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) Participate in required project teams.
- Conduct validation training with site teams communicating deliverables, procedures and methods
- Coordinate with Technical Operations group to ensure alignment on technical standards and project execution for technical transfer projects/NPI.
- Cooperate to troubleshoot business and technical issues impating equipment to establish what is being done and where improvements are possible.
- Maintains professional and technical knowledge by attending educational seminars and trade shows, reviewing professional publications and analyzing new trends.
- Lead execution of C&Q CSV related parts of projects and initiatives in the site, as well as support C&Q CSV related for platforms and across sites.
- Ensures attainment of projects related C&Q/CSV activities to scope, schedule and budget
- Define C&Q CSV capital evaluation and support capital appropriations required for new projects
- In alignment with EMa lead, keeps senior management informed on C&Q CSV projects and program status by creating, maintaining, and presenting written reports on project and program status, tests, costs, issues, and performance against established targets on a regular basis.
- Provides technical leadership of cross functional teams on many different projects/ process improvements and resolves inter-functional issues including master planning support.
- Ensures the documentation of project and program activities and deliverables are timely set up and available.
- BS 5-8 yrs. MS/Ph.D. 3 yrs. PE, PMP Certificates helpful
- Proven track record in C&Q and CSV tasks within Project Engineering/Management in the pharmaceutical industry
- Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
- Strong knowledge of computerized system development life cycle approach is required.
- The ability to work and make decisions independently and have the flexibility to adapt to changing Strong understanding of Pharma business and manufacturing requirements (EHS, Quality and operations).
- Strong communication skills.
- Ability to keep the pressure and composure in potentially uncomfortable situations.
- Fluent English & Mandarin.
Xian-Janssen Pharmaceutical Ltd. (7043)