담당업무

ㆍcGMP 승인 project manage team의 manager

ㆍApply cGMP knowledge to drive multiple site improvement projects and actions 

   in the vaccine manufacturing plant

ㆍManage multiple, small to medium complexity cross-functional GMP process 

    improvement projects with small to medium size group (2 to 10)

ㆍDevelop and manage project timeline that aligns with the overall site QE timeline

ㆍServe as a project manager, tracking overall project timeline and its elements to 

   ensure that functional deliverables are completed on time and according to 

   quality standard

ㆍProactively identify project risks and work with the team and a group of SMEs to 

   develop a contingency plan

ㆍPrepare a routine project status report  

ㆍPromote a quality-based GMP culture of collaboration, cooperation, execution, 

   effective communication and cross-functional problem-solving to enable 

   high-performance team

필수요건

ㆍ학력 : 학사 이상

ㆍ전공 : 생명공학, 생물학, 미생물학, 화학 등 유관학과

ㆍ경력 : 유관 경력 5년 이상

ㆍ어학 : 비즈니스 영어 능통자

ㆍTechnical 영어 문서 작성 가능자

ㆍFDA/EMA 실사 대응 경험자 as an SME

ㆍcGMP 승인 프로세스 경험자

ㆍMust have experience in leading projects

ㆍMust have excellence organization and time management skills

ㆍExperienced with regulated GMP environment

ㆍMust have highly organization skills with the ability to manage multiple tasks in parallel

우대사항

ㆍManufacturing (DS/DP/Aseptic processing) or QC experience is a plus

ㆍExperienced in cGMP computer system management is a plus