1. 담당 업무
|
l
Maintenance of existing product
licenses
l
KGMP certificate renewal
l
Compliance with MFDS &
Corporate QA requirements
l
Management of internal/external KGMP
audit/inspections as company representative.
l
Document control: Device Master
File, SOPs and Quality manuals
l
Quality oversight of the storage
and release testing of products
l
Manage deviation and
CAPA(Corrective Action Preventive Action) 2. 희망 경력 |
|
§ Prepare
for the successful KGMP on-site audit by MFDS/NB
- Prepare
for the successful KGMP renewal by MFDS/NB in every three years
- Communicate
with manufacturing sites to get the required documents and dossiers on time
- Prepare/revise/control
local DMR and SOP to ensure compliance with the Corporate and the MFDS requirements
for Dentsply Sirona Korea operation
- Adverse
events reporting
- Support
product complaint handling and take appropriate actions to ensure overall
Korea regulations
|
-Experience
of UDI (unique device identifier), UDI database and deep knowledge of MFDS
requirements
- Experience
with the design and implementation of a UDI for medical device units
-Label
Verification: Ensure data accuracy between labels and master UDI data
| 3. 자격조건
|
- 유관 경력 3년 이상
- Experience in registering
an implantable medical devices (Class3~4)
- Fluent in English
4. 기타
- 산휴대체 <계약직> 임
[제출서류]
- 워드 양식의 국문/영문 이력서 각1부 (경력 기술서,,사진 유첨)
적합도가 현저히 낮은 경우 연락 드리지 않을 수도 있음을 양해 바랍니다.
* 후보자는 헤드헌팅에 관한 비용이 없습니다.(고객사부담)
◈ VISION 2010 경영 혁신 大賞 수상`
◈ 2010 한국컨설팅 대상 HR부문 대상 수상`
◈ ISO 9001:2008 인증 기업
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담당: 원경림 이사
유선: 02-6925-3341
무선: 010-2751-5485
메일: won@bbp.co.kr
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