Support the Business Quality Manager to fulfil the responsibility for the coordination and execution of all Quality Management System activities across Janssen Hong Kong.
Support Hong Kong Business Quality team and Local Operating Company to meet all company compliance standards and regulations.
Support the oversight of Quality Management System (QMS) of Janssen HK, including supplier management, change control, risk assessment, deviation and CAPA review.
Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.
Coordinates change control documentation and approval process.
Makes proposals and assists in the development of corrective action plans and monitors implementation.
Follows up on closure of corrective and preventive actions. Provides quality support for technology transfer and improvement of existing manufacturing processes.
Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.
Prepares for and facilitates audits and inspections. Monitors trends, identifies issues, recommends and implements appropriate actions.
Assists in the development, implementation and review of standard operating procedures for interactions with contract manufacturers.
Responsible for maintaining Training Program.
Work collaboratively with cross functional local teams and regional affiliates to ensure consistency of approach across groups.
Experience, Skills and Knowledge :
At least 2 years of experience in QA related field essential; experience working in the pharmaceutical industry is strongly preferred
Experience in conducting training
Knowledge of local Health Authority regulations
Demonstrated attention to details
Excellent written and spoken communication and presentation skills
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Sound judgment, strong planning and organizational skills, and the ability to get things done
Demonstrated strong sense of urgency
China-Hong Kong S.A.R.-Mongkok-
Johnson & Johnson (Hong Kong) Ltd. (8060)