Clinical Quality Manager
- Company
- 외국계 제약회사
- Position
- Clinical Quality Manager
- Status
- CLOSE
외국계 제약회사에서 다음과 같이 “Clinical Quality Manager” 를 찾습니다.
* Job Title: Clinical Quality Manager
* Position: 과장 - 대리급
* Gender: Male or Female
* Location: Seoul
[Position Overview]
Primarily responsible for implementing the Quality Management System and all associated documentation requirements
[Responsibilities]
- Audits
1. Annual audit planning (Internal & external)
2. Study-related Audit (Documents, Site)
3. System Audit
4. Third party Audit (CRO, center clinical laboratory..)
5. Selection and management of contracted auditors
- Quality Controls
1. Trial-specific QC Planning
2. QC visits
3. Quality Improvement
4. Develop, recommend, and monitor corrective and preventive actions
- SOP management
1. Creating and Approval
2. Implementing Upholding
3. Distribution and Archiving
- Mock Regulatory Inspection
1. Regulatory inspection preparation
2. Coordination and management
- Training & Regulatory update
1. Initiation and maintenance of personnel files (CV, JD, Training record)
2. Training and professional development planning
3. Reference material management
4. Maintain and management for clinical trial related association
- Other
1. QA related documents management
[Qualifications]
- Minimum 10 years of pharmaceutical industry experience.
- Minimum 5 years of QA, QC or CR.
- Bachelor’s degree or above, preferred major in pharmacy, science,
engineering or related field required.
- Experience in Quality Compliance of Clinical
- Experience at a generic drug company is preferred.
- Excellent oral and written communication skill in English.
- Able to work independently and with others.
Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently. Only qualified candidates will be contacted for interview. All resumes not contacted will be kept in DB confidentially for future positions.
Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc.
Mobile: 010-8722-1272
Email: ceo@exdigm.com
