Main Tasks & Responsibilities:
1.Set up instrument assembly ,commissioning and packaging equipment,
respective organization and Production process during the project phase.
* Participation IQ/OQ and engineering run and perform PQ
* Ensure all processes are defined and described in standard operations
procedures (SOPs) and implement manufacturing instructions
* Build-up operations instrument assembly, commissioning and packaging team
2.Responsible for the hands-on, daily supervision of GMP manufacturing
operations and personnel within the manufacturing site(s).
3.Lead the team to achieve team target, participate in all aspects of
personnel management (training,coaching and developing).
* Allocate and balance work across subordinates
* Review and provide timely performance feedback to subordinates;
* Mentor, develop and motivate subordinates;
* Provide technical training and support to sub-ordinate employees;
* Monitor and implement the company discipline policy
* Resolve people/functional issues in the production in order to improve
effectiveness and achieve targeted department performance.
* Provide cross-functional coordination and issue resolution.
4.Monitor work to ensure quality, and continuously promote Quality Right First
Time and aim to continuously improve the efficiency of manufacturing operations
* implement manufacturing department quality target and monitor the
operations quality status ;
* involve quality issue's analysis and improvement, implement the related
action plan.
* supervise and monitor production process against production plan;
* monitor emergency solving process in order to ensure smooth production and
meet productivity and Quality targets.
5.Write and revise batch records, SOPs and solution preparation documents to
ensure compliance to GMPs.
6.Review and approve inventory count plan in order to find out the variance
against the standards;
7.Review workshop's Process Order(PO) and then pass to Finance for further
analysis in order to balance all resources for production
8.Schedule manufacturing staff to ensure manufacturing timelines are met
9.Review production schedule and priorities to establish shift assignments
10.Provide cross-functional coordination and issue resolution
11.Planning & Budgeting
* Propose and recommend manufacturing strategy;
* develop and implement production budget and plan;
* monitor the achievement of the budget; in order to achieve annual
manufacturing goals.
12.Implement Transfer of existing, relevant sending site requirements to fit
Suzhou site needs and ensure these requirements are defined for all positions
in the dispenser Operations team
13.Other tasks assigned by line Manager
Qualification & Experience:
Education
* College Degree or above, Had the education background of Manufacturing,
Engineering or equivalent. Major in Electronic, Electrical or Mechanical is
preferred.
Qualification & Certification
* Experience with SAP
* ISO 13485 or cGMP
Experience
* 3 years’ experience in a highly regulated cGMP manufacturing environment
* 6 - 10 years’ experience in manufacturing, including min. 4 years
managerial experience
* Working experience in medium-to-large-scale enterprise is preferred
* cGMP or medical device experience is preferred
Professional Competencies
* Production Expertise
* Professional and positive approach with learning agility
* Self-managed, and can complete assigned tasks independently
* Good team player
* Effective communicator at project working stream and sub working stream
level
* Ability to execute and support the concepts to stream and sub-stream levels
* Assertive, adaptable and creative
* Dynamic and vigorous, and willing to learn
* A “can-do” attitude and willingness to go the extra mile when required
* Cultural awareness and the ability to work with a broad range of cultures
* Fluent in English listening and speaking