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Job Summary
Leads, supports or advises Commissioning & Qualification (C&Q) activities related to manufacturing and storage facilities and systems, laboratory buildings and equipment, utilities generating and distributing facilities and systems, generally in conjunction with CAPEX projects. Contributes to Right First Time delivery of those facilities and systems in quality, on time and in budget which is compliant to GMP, Chinese laws and represents Roche in an adequate way.
Main Tasks & Responsibilities
Directs the planning, organization, and coordination of commissioning and qualification activities of manufacturing and storage facilities and systems, laboratory buildings and equipment, utilities and infrastructure.
Review of respective Engineering, Commissioning and Qualification documents of CAPEX projects in scope.
Identification of quality issues in CAPEX projects in scope of work of the Commissioning and Qualification Manager in cooperation with Project Managers and Engineers, analysis of those and mutual development of mitigation measures.
Develops commissioning and qualification plans and schedules for the respective facilities and systems incl. material, staffing and budgeting.
Leads and coordinates commissioning and qualification teams and/or participates in such teams.
Works in cooperation with the Project Manager, Engineering, Automation, User, Suppliers and Quality Unit to achieve a smooth handover of the systems to the owner and operational personnel.
Contributes to, or leads the development of procedures, guidelines and other documents related to commissioning and qualification as needed or participates in respective teams.
Participates in quality meetings or contributes to those as delegate of the Engineering.
Performs and supports coaching, training and development of qualification and commissioning engineers.
Conduct business in full compliance to Behavior in Business and Behavior in Competition.
Responsibilities:
Ensures compliance with Roche Quality Standards, with applicable health authorities' requirements and with current Good Manufacturing Practices (cGMP) for qualification activities in scope of work of the Qualification Engineer.
Provides reliable qualification schedules for CAPEX projects based on duly described project scope and requirements.
Provides reliable commissioning plans and schedules for CAPEX projects based on duly described project scope and requirements.
Provides realistic cost estimates of qualification and commissioning work based on duly described project scope, requirements and anticipated schedule of the particular project or sub-project.
Experience:
Field experience in commissioning and qualification activities of diagnostics / pharmaceutical / biotech manufacturing facilities and systems for mid- and large-sized investment projects.
Solid collaboration and influencing skills and the ability to lead diverse, cross-functional teams in international environments.
Excellent communication skills in Chinese and English, further languages are beneficial. Proficiency in both spoken and written English.
Education & Qualifications:
Master or Bachelor degree in engineering, in natural science or pharmaceutics with long time experience in diagnostics / pharmaceutical / biotech industries.
In depth diagnostics / pharmaceutical / biotech Commissioning and Qualification knowledge. Strong experience in GMP, GEP and application of Quality Systems.
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Roche is an Equal Opportunity Employer.