유명 바이오 제약회사에서 다음과 같이 'CQA (Clinical QA) Manager'를 찾고 있습니다.
* Position: CQA (Clinical QA) Manager
* Department: Program Management
* Location: Songdo

[RESPONSIBILITIES]
- Risk Management in GCP/PV perspective
- Audit (Clinical investigational site, CRO, vendor, internal system including PV, etc.)
- SOP management
- GCP training
- Set-up Quality Assurance system for PV

The duties assigned to associate manager, Clinical Quality Assurance (CQA) are as follows:
- Update, notify and maintain SOPs.
- Prepare SOP (general and CQA) and review other SOPs to keep the consistency.
- Prepare SOP training materials and provide or coordinate trainings in regards to SOPs (General/CQA), GCPs, and other relevant regulations and policies as needed.
- Planning, conduct, reporting of audits.
- Ensure implementation of the adequate follow-up activities, corrective and preventive actions of audit findings.
- Host the regulatory authority inspection of sponsor.
- Review the documentations related to CQA activities.
- Archive the SOP related documentations and CQA related documentations.

[QUALIFICATIONS]
- Bachelor’s degree or above (Major: Pharmacy, Nursing preferred)
- Registered pharmacist or registered nurse
- At least 2 years Clinical QA experiences, or
- At least 3 year CRA or Clinical QC experiences, or
- At least 2 years PV experiences
- Should speak and write Korean and English to good standard
- Have strong analytical, interpersonal and communication skills.
- Ability to develop and interpret policies and to perform multiple tasks
- Accurate, well-organized, sincere, discreet and honest characteristics
- Excellent written and oral communication skills
- Good time management and prioritization skills regarding travel and other duties
- Familiar with Clinical trial, or CRA activity (source data verification), or PV activity, or Medicinal products

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
Phone: 070-8260-3646
Mobile: 010-8722-1272
Email: ceo@exdigm.com