The Quality Assurance Specialist will be responsible for ensuring that products and services meet the established standards set by the company. The goal is to maintain strong overall quality control of products made by the company adhering to reliability, performance and customer expectation.
[GMP Quality Systems]
- Manage GMP Quality Management Systems (QMS), including document control, change control, and training management.
- Manage and maintain laboratory and manufacturing equipment.
- Perform environmental monitoring activities.
- Ensure and maintain data integrity compliance.
Qualifications
- Bachelor's degree or higher.
- Entry-level candidates and experienced professionals are both welcome.
- Strong understanding of GMP regulations and quality systems.
- Experience or knowledge related to GMP quality system operations.
- Ability to understand English documentation and communicate effectively in English.
Preferred Qualifications
- Experience implementing and operating GMP electronic systems such as eQMS and eDMS.
- Experience in risk assessment and data integrity management.
- Experience supporting inspections by domestic and international regulatory authorities.
- Experience responding to audits and inspections conducted by regulatory agencies.
