Job Responsibilities
Support the start-up of Quality Systems for the site. Execute and maintain the Quality Systems at the site. Document Management System Write, Revise, Review and Approve Standard Operation Procedure, protocols, reports or records. Conduct training Provide guidance on Current Good Manufacture Practices, Good Documentation Practices and Data Integrity requirements. Training/Learning Management System Maintenance of training curriculum/tasks. Custodian and archival of training records. Provide guidance on Learning Management System usage. Trackwise System Provide guidance on deviation management, change control and Corrective And Preventive Actions Conduct training and provide guidance on trackwise system usage. Communicate quality systems and compliance requirements effectively to peers and stakeholders. Provide compliance support to staff in all departments. Participate in regulatory, customer and internal audits. Any other tasks as and when assigned by the supervisor/line manager.
Job Requirements
Familiarity with Regulatory requirements and local Codes & Standards (e. g. , Food and Drug Administration, European Agency for the Evaluation of Medicinal, Good Automated Manufacturing Practice and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) Good knowledge and experience of the practical and theoretical requirement of validation program in Good Manufacture Practices facility Good leadership skills Strong interpersonal skills Effective Communicator (oral and written) Exhibit good quality decision making traits Meticulous and Systematic Analytical Mind Ability to define specific goals clearly, to develop and prioritize activities Team player, with strong focus on safety, quality and timelines
Required Languages
English
Job Details
Position type
Medical device R&D/production
Experience
3~5 years