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職位
Engineering Project Support and Operation Readiness:
● Play the role of process equipment representative to contribute on project design, construction and qualification, including but not limited design, equipment selection, URS review, FAT, SAT, IOPQ to contribution on project delivery.
● Lead filling and packaging maintenance team coordinate with Engineering department, production department, quality department, vendors, etc for cooperation to achieve the positive goal.
● Establish and develop the production and lab equipment maintenance operation system in alignment with the Roche standards including maintenance management system, people training and qualification, CCS strategy and implementation to support robust operation readiness.
● Support manager to develop a competent team through coaching, mentoring and training by having in place a skill competencies development and appraisal program to strengthen the technical expertise and capabilities.
● Participate in tech transfer, collaboration with other function to ensure the success of new product manufacturing.
● Represents the process equipment during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.
Routine Operation:
● As the system owner, accountable for the operation and maintenance of production and lab equipment, manage the relevant maintenance with Roche’s GMP/EHS standards and regulatory guidelines. Enhance production and QC lab operation through implementation of an effective maintenance and operation program, work prioritization, complying with operational and personnel standards, regulatory and statutory requirement to ensure efficient, reliable, and uninterrupted plant operation.
● Responsible for Planning of maintenance activities with various departments to ensure resources, parts and vendors are on site per schedule for maintenance work. Execute preventive and corrective maintenance programs and specific maintenance plans for production and QC lab assets that maximize equipment availability and to optimize life-cycle costs.
● Ensure audit readiness by complying with effective standards, regulatory/statutory and cGMP requirement to protect product and to prevent major compliance observation.
● Responsible for the Quality and Accuracy of data and records of relevant equipment and maintenance.
● Involve in the deviation investigation and CAPA execution, including appropriate escalation where needed to ensure closure within the set timeline.
● Support to drive continuous improvement by providing recommendation and initiative to promote sustainability (Energy