Company and Job Overview
This company is dedicated to researching and developing drugs for rare diseases. It aims to provide top-quality medications to improve patients' health and quality of life. As a leading entity in the orphan drug market, the company partners with major pharmaceutical wholesalers to ensure an efficient distribution network.
Job Responsibilities
Quality Representation and Audit Preparation:
Support the company in all quality-related matters and prepare for audits by competent authorities (e.g., BfArM, UK MHRA) to ensure conformity.
Document and Procedure Management:
Manage and update the company document system and management manual, and coordinate the definition and distribution of company procedures.
Quality System Audits and Evaluations:
Plan and supervise quality system audits, evaluate necessary corrective actions (CAPA), and assess audit results and non-conformities.
Training and Technical Assistance:
Provide training on quality system issues and methodologies, offer technical expertise to other company functions and projects, and implement necessary training programs.
Job Requirements
Capable of handling multiple tasks simultaneously.
Proficient in English at a business level (reading, writing, and speaking).
Experience in creating manuals and procedures is a plus.
Benefits
Opportunities to gain diverse experiences.
Due to the high volume of applicants, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.