외국계 제약회사에서 다음과 같이 "ESQ Lead” 인재를 찾습니다.

* Job Title :  위탁생산 품질관리총괄 (ESQ Lead – External Supply Quality Lead)

* Position :  부장 – 차장급

* Report to APAC / Quality Team

* Gender :  Male or Female

* Location:  경기도

 

[RESPONSIBILITIES]

{CMO assessment, approval & compliance}

: for defining which CMOs, within role scope may be considered for remote assessment and which require on-site audits.

: for ensuring adequate alignment of Company audit standards within the Company QMS.

: management of the execution of assessment / audit of CMOs, within Taiwan or Korea and if need be in APAC as per pre-defined / agreed audit plan.

: reviewing and approving CMO audit reports.

: confirming proposals regarding the continued use of CMOs with marginal compliance.

: ensuring data management of auditee profiles remains current.

: ensuring supply chain risk assessments are in place for relevant CMOs in APAC.

: supporting QTA negotiations and CMO change controls for CMO is scope and in APAC, as appropriate.

: assessing, approving and managing audit requests for new and in use suppliers / CMOs in APAC.

 

{Risk assessment}

: collating identified risks and escalating high risk issues / situations to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified.

: ensuring any learnings from incidents are communicated across APAC quality.

: direct investigation into significant quality incidents arising at CMOs and ensure root cause of the problem is identified and appropriate CAPAs are implemented.

: communicate results of investigations and/or identified risks to ensure stakeholders understand the technical, regulatory and quality risks.

: Develop quality risk model for CMOs and use the output to identify low control CMOs and engage stakeholders

 

{Regulatory inspection support}

: Responsible for managing adequate External Supply Quality related support to Lotus  and Korean sites/ CMOs for regulatory inspections

 

{Internal External Supply Quality processes}

: authoring / revising assigned ESQ procedures, participating in the development of the ESQ processes, performance management to ensure compliance with Company QMS.

: ensuring that training is current for self as well as all staff reporting to job role.

: participating in the development of tools, techniques and processes that will be used to improve quality and compliance of the supply base; eg how quality review meetings will be managed and what metrics for use etc.

 

[QUALIFICATIONS]

- Bachelor’s degree (major: pharmacology, chemistry, biology, molecular biology or biochemistry)

- Relevant experience in pharmaceutical industry is required below: 10 years above of the relevant experience

- English requirement: Fluent

- Experience with US/EU/Local Regulatory inspections

- Familiar with GAMP, TFA, CFR Title 21, EudraLex Vol.4

Those who are interested in this opportunity, please submit your Resume (CV) 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.

 

KIM, Kyung Jin (Ian Kim)

CEO / Exdigm Inc.

E. ceo@exdigm.com

U. www.exdigm.com