Plan and promote appropriate quality control, manufacturing control, and safety management based on QMS, GVP, and the Pharmaceutical and Medical Device Act for products and services handled
Job Summary
Plan and promote appropriate quality control, manufacturing control, and safety management based on QMS, GVP, and the Pharmaceutical and Medical Device Act for products and services handled.
Establish procedures and ensure records are created and stored to guarantee that new products and services are safe and comply with domestic regulations by predicting and evaluating risks.
Ensure internal and external audits are conducted appropriately based on applicable standards and that the QMS is continuously improved.
Matching Summary
Plan and promote appropriate quality control, manufacturing control, and safety management based on QMS, GVP, and the Pharmaceutical and Medical Device Act for products and services handled.
Skills & Requirements
Must-have
QMS, GVP, and PMD Act knowledge
Risk assessment and mitigation
Internal and external audit management
Regulatory authority liaison
Effective communication with global colleagues
Nice-to-have
Fostering a quality assurance culture
Coaching and training staff
Proactive response to regulatory changes
Key Requirements
Knowledge of QMS, GVP, and PMD Act
Ability to plan and prioritize multiple tasks
Ability to assess risks and formulate risk reduction measures
Ability to understand accurately and make appropriate decisions based on evidence
Ability to plan and coordinate execution with stakeholders