招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
Job Summary:
Develop and implement printing processes, supervise and control related in-house printing equipment, as well as at external local/overseas suppliers, with the objective of meeting the production volume, schedule, quality and safety requirements within the Printing/Packaging & Labeling Department according to Roche policies, procedures guidelines.
Main Tasks & Responsibilities:
1.Subject Matter Expert in the area of Print Media processes, responsible for the hands-on, daily supervision of GxP printing operations within the Roche manufacturing site(s) and at approved vendor site(s).
2.Technical coordinator at Asia Manufacturing site regarding Label Content management, (AIDA application), including interface with in-house regulatory affairs and external vendors regarding the localization of product labels with Chinese Label Content.
3.Ensures regulatory compliance with IVD, Quality System and GxP rules including ensuring the continued availability of qualified and valiated status of equipment and vendors of printed media
4.Monitors work to ensure quality and continuously promote Quality First Time, setting targets internally and at external vendors, aiming to continuously improve the efficiency of printing operations
a.implement printing department quality target and monitor the operations quality status;
b.involve quality issue's analysis and improvement, implement the related action plan.
c.monitor printing processes against printing plan;
d.monitor emergency solving process in order to ensure smooth production and meet productivity and quality targets.
5.Create and revise SOPs and solutions documents to ensure GxP compliance
6.Provide cross-functional coordination and issue resolution including project-related responsiblities
7.Planning & Budgeting
a.Propose and recommend manufacturing/printing strategy;
b.develop and implement production budget and plan;
c.monitor the achievement of the budget; in order to achieve annual manufacturing goals.
8.Implement Transfer of existing, relevant DOM (Diagnostics Operations Mannheim) requirements and business processes to fit AM needs
9.Responsible for the initiation and coordination of Change processes in the scope of Product responsibility
10.Other ad hoc tasks
Basic Requirements of the Job:
Education & Qualifications:
Bachelors Degree in Manufacturing, Technology, Print Media; (preferred MedTech) or equivalent by experience
Experience:
Working years (in any specific area)
a.3-5 years experience in a highly regulated cGMP manufacturing environment
b.6 years experience in print manufacturing, including min. 4 years managerial experience
IT Skills
At least 2-3 years’ experience in SAP
Tools & Methods Skills
Knowledge of TPM (total productive maintenance) is recommended
PM Skills
Solid experience in project management
Language skills
a.Native or fluent Chinese
b.Fluent English
Leadership Competencies:
Leadership competencies at proficient level, in line with corporate framework.
Professional Competencies/skills:
a.Ability to convey concepts to different management levels and across functions within the organization/project
b.A "can-do" attitude and willingness to go the extra mile when required
c.Business Expertise
d.Achieving Results
e.Teamwork and Collaboration
f.Inspiring and Influencing
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