ÅëÇÕ°Ë»ö
ä¿ëÁ¤º¸
ÇìµåÇåÆÃ
ÀÎÀçÁ¤º¸
Ä¿¹Â´ÏƼ
Àαâ°Ë»ö¾î
:
¿µ¾÷
¸¶ÄÉÆÃ
ÀÓ»ó
¿¬±¸
Ç°Áú°ü¸®
ÀλçÃѹ«
»ý»êÁ÷
¾à»ç
ÀÎÇã°¡
°£È£»ç
- À̹ÌÁöºä -
(400x300)
QA - Commercial Affiliates Quality Assurance Pharmacist -¿Ü±¹°èÁ¦¾àȸ»ç
http://www.hrkorea.co.kr
ȸ»ç¸í
HRKorea
´ëÇ¥ÀÚ
¼Á¾¿ø
»ç¿ø¼ö
35¸í
ÀÚº»±Ý
25¾ï¿ø
»ç¾÷³»¿ë
Á÷¾÷Á¤º¸Á¦°ø
¸ðÁýÁ÷Á¾
¿¬±¸/ÀÓ»ó/°³¹ß/Åë°è
£¾
¿¬±¸/¿¬±¸±âȹ
±Ù¹«Áö¿ª
¼¿ï
ÀüÁö¿ª
´ã´ç¾÷¹«
QA - Commercial Affiliates Quality Assurance Pharm
¸ðÁýÀοø
1
¸í
±Ù¹«ÇüÅÂ
Á¤±ÔÁ÷
±Þ¿©»çÇ×
´ç»ç±ÔÁ¤¿¡ µû¸§
ÀÚ°Ý¿ä°Ç
¼ºº°
¹«°ü
³ªÀÌ
¹«°ü
ÇзÂ
´ëÇÐ(4³â) Á¹¾÷
¡è
°æ·Â
4³â
¡è
¾÷Á¾
Á¦¾àȸ»ç/ÀǾàÇ°µµ¸Å
±â¾÷ÇüÅÂ
´ë±â¾÷
»óÀå¿©ºÎ
ÄÚ½º´Ú
»ó¼¼¸ðÁý³»¿ë
QA - Commercial Affiliates Quality Assurance Pharmacist -
¿Ü±¹°èÁ¦¾àȸ»ç
Job Description:
Quality management, and oversight processes within Korea under his/her responsibility.
The major responsibilities will include but are not limited to:
¡¤
Ensure implementation of and on-going compliance with applicable regulatory requirements for all GxP areas i.e. GMP, GDP and the Company Code of Ethic, Policies, and Quality Guidelines as well as with Industry Best Practices and that non-compliance is appropriately addressed via Corrective and Preventive Actions (CAPA) and/or escalation of issues.
¡¤
Design, implementation and maintenance a Quality Management System to assure pharmaceutical products and medical devices quality in commercial affiliate and supply chain.
¡¤
Drive together with the Commercial Affiliates Quality Units and the Commercial Affiliates Head the creation and implementation of a consistent quality culture across countries in the respective region.
¡¤
Support quality activities in supply chain and traceability of products in Korea.
¡¤
Drive the implementation of the Regional Quality Organization on local level. Ensure implementation of applicable Quality Standards and governance processes through the implementation of the Company Policies and Quality Guidelines.
¡¤
Ensure implementation of defined Key Compliance / Quality Indicators KC/QI in the region to monitor on an on-going basis that relevant processes are in control and compliant as well as that regulatory controls are in place in relevant process steps.
¡¤
Regularly review and assess KC/QIs of the concerned region. Ensure that potential compliance gaps and risks are addressed and opportunities for continuous improvement identified and the annual Regional Quality Plan implemented in the countries.
¡¤
Provide quality oversight for deviations, investigate root cause and ensure real root causes are clearly identified and adequate CAPA
¡¯
s are implemented.
¡¤
Provide quality oversight for change control process to ensure all local changes are compliant to GMP and company guideline.
¡¤
Provide quality oversight in complaint handling and product recall, investigate root cause, ensure related procedure are strictly implemented and quality events are successfully solved.
¡¤
Liaise effectively across e.g. TechOps Supply-Chain, Regulatory Affairs and Procurement to ensure that global processes are adequately implemented and projects are successfully launched in the countries.
¡¤
Ensure that proper Quality oversight is implemented in countries for 3rd parties/vendors/outsourced activities.
¡¤
In liaison with the local GM&RA Ensure effective communication with local Health Authority is adequately shared within the organization and commitments tracked and closed on time, including coordination of product recall, issue of new regulation and submission of changes to Health Authority. Inform CQM about all the requests or regulatory alert fields by the local regulatory agencies;
¡¤
Prepare and implement Health Authorities Inspection, Internal Corporate Audit and Third Party audits
¡¤
Support RA manager for various global and local RA&QA projects
¡¤
Management of local product labeling to comply with local regulations and update timely
Desired background & Experience:
Degree in Pharmacy is preferred.
A minimum of 4 years of Quality Assurance experience and involvement in pharmaceutical or medical device industry; broad understanding of global expectations of Health -Authorities in the GMP, GDP, ISO 13485, ISO 9001 and Pharmacovigilance.
A minimum of 4 years of demonstrated QA experience in commercial affiliates and supply chain in a global/matrix environment in the pharmaceutical industry
Strong management, interpersonal, communication, negotiation and problem solving as well as project management skills
Knowledge and experience of audit, validation, CAPA, risk assessment, data analysis is highly appreciated.
Assertive and Diplomatic behavior. Considerable organization awareness e.g. interrelationship of departments, business priorities, including significant experience working cross-functionally and in global teams.
Demonstrated experience of successfully leading an organization or projects with high impact.
Fluent English in speaking and writing; knowledge of languages spoken in the respective region is a plus.
Ability to travelling and good cooperation in team.
*
¼·ùÁ¢¼ö
E-mail :
kschoi@hrkorea.co.kr
´ã
´ç
: HR Korea
ÃÖ°æ¼÷ºÎ»çÀå
Tel. : 02-3450-1263
Á¢¼ö±â°£
ä¿ë½Ã
Á¢¼ö¹æ¹ý
À̸ÞÀÏ, ¿Â¶óÀÎÁ¢¼ö
À̷¼¾ç½Ä
¿Â¶óÀÎ À̷¼
´ã´çÀÚ
ÃÖ°æ¼÷
¿¬¶ôó
02-3450-1263
À̸ÞÀÏ
kschoi@hrkorea.co.kr
ȨÆäÀÌÁö
http://www.hrkorea.co.kr
ȸ»çÁÖ¼Ò
[137-861] ¼¿ï ¼Ãʱ¸ ¼ÃÊ2µ¿ 1340-6 ³²°ºôµù 11Ãþ
ÃÖÁ¾¼öÁ¤ÀÏ : 2020³â 10¿ù 27ÀÏ
º» Á¤º¸´Â HRKorea¿¡¼ Á¦°øÇÑ ÀÚ·áÀ̸ç, Æĸ¶¸ÞµðÀâ´Â(Àº) ±âÀçµÈ ³»¿ë¿¡ ´ëÇÑ ¿À·ù¿Í Áö¿¬, »ç¿ëÀÚ°¡ À̸¦ ½Å·ÚÇÏ¿© ÃëÇÑ Á¶Ä¡¿¡ ´ëÇÏ¿© Ã¥ÀÓÀ» ÁöÁö ¾Ê½À´Ï´Ù. º» Á¤º¸´Â Æĸ¶¸ÞµðÀâÀÇ µ¿ÀÇ ¾øÀÌ Àç¹èÆ÷ÇÒ ¼ö ¾ø½À´Ï´Ù.
¼±ÅÃÇϽŠÀ̷¼¿Í ÀÔ·ÂÇϽŠ³»¿ëÀÌ ÇØ´ç¾÷üÀÇ ´ã´çÀÚ¿¡°Ô À̸ÞÀÏ·Î Àü¼ÛµË´Ï´Ù.
Áö¿øÀ̷¼
À̷¼¸¦ ¼±ÅÃÇØÁÖ¼¼¿ä
´ã´çÀÚ¸í
ÃÖ°æ¼÷ (kschoi@hrkorea.co.kr)
º¸³»´Â»ç¶÷
³»¿ë
°³ÀÎÁ¤º¸Ã³¸®¹æħ
|
ȸ¿ø¾à°ü
|
°í°´Áö¿ø¼¾ÅÍ
|
Á¦ÈÞ ¹× ±¤°í¹®ÀÇ
|
´ÙÀÌ·ºÆ®°áÁ¦
¼³¸³ÀÏ : 2015³â 12¿ù 02ÀÏ l °³ÀÎÁ¤º¸Ã¥ÀÓÀÚ : À±º´È£
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003
»ç¾÷ÀÚµî·Ï¹øÈ£ : 285-18-01963
| Åë½ÅÆǸž÷½Å°í : Á¦ 2023-ÀÎõ-0450È£
Copyright ¨Ï
Æĸ¶¸ÞµðÀâ
Co. Ltd. All rights reserved.